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<h3>Job Description</h3>
Job Description
About the Role The Food Safety and Quality Assurance Manager is responsible for leading all aspects of food safety, regulatory compliance, and product quality within a food manufacturing environment. This role ensures that the facility maintains full compliance with SQF certification standards, FDA/USDA regulations, and internal quality systems. The ideal candidate will bring strong leadership, technical expertise, and a hands-on approach to managing food safety programs and maintaining third-party certifications such as SQF, HACCP, and FSMA.
Responsibilities:
<ul>
<li>Manage and oversee all food safety and quality assurance programs to ensure compliance with SQF, HACCP, FSMA, and other regulatory standards</li>
<li>Lead internal audits and inspections, including GMPs, pre-operational checks, and Food Defense evaluations</li>
<li>Prepare for and lead third-party audits and regulatory inspections for SQF, Organic, Gluten-Free, Non-GMO, and other certifications</li>
<li>Develop, implement, and update key documentation such as Food Safety Plans, SOPs, HACCP plans, GMPs, and prerequisite programs</li>
<li>Conduct validation and verification activities to ensure food safety systems are functioning effectively</li>
<li>Investigate and resolve food safety or quality issues, including customer complaints and supplier non-conformances</li>
<li>Monitor and maintain documentation for production records, batch logs, and quality forms</li>
<li>Manage compliance and certification for Kosher, Organic, Gluten-Free, and Non-GMO product lines</li>
<li>Communicate updates in food safety legislation and regulatory changes to internal teams</li>
<li>Promote and maintain a strong food safety culture across all departments</li>
<li>Perform routine testing of raw materials, in-process products, and finished goods</li>
<li>Support cross-functional teams in continuous improvement of food safety and quality programs</li>
<li>Execute additional QA/QC-related duties as needed</li>
</ul>
Qualifications:
<ul>
<li>Bachelors degree in Food Science, Microbiology, Biology, or a related field preferred</li>
<li>Minimum of 3 years of experience in food safety or quality assurance within an FDA- or USDA-regulated food manufacturing environment</li>
<li>SQF Practitioner certification and experience leading SQF programs</li>
<li>HACCP and PCQI certifications required</li>
<li>Strong knowledge of FSMA, GFSI, and food manufacturing best practices</li>
<li>Experience conducting internal audits and preparing for external audits</li>
<li>Proficiency in Microsoft Office and quality management systems</li>
<li>Excellent communication, analytical, and documentation skills</li>
<li>Strong attention to detail and ability to manage multiple priorities in a fast-paced environment</li>
<li>Must be authorized to work in the United States</li>
</ul>
Desired Qualifications:
<ul>
<li>Experience managing certifications such as Kosher, Organic, Gluten-Free, and Non-GMO</li>
<li>Familiarity with laboratory testing in a food production setting</li>
<li>Proven ability to lead cross-functional teams and foster food safety culture</li>
<li>Valid drivers license and ability to travel as needed for audits or vendor visits</li>
</ul>

Food Safety Quality Assurance Manager

<h3>Job Description</h3>
Job Description
Position Summary:
The IT Business Systems Manager will be the IT System Owner to the quality learning management system (LMS), quality management system (QMS), and electronic document management system (eDMS). Their primary role is to partner with the Quality team to ensure the ComplianceWire and Vault Quality solutions are meeting the needs of the cross-functional GxP business community.
This individual must have a deep understanding of the Veeva Vault Quality specifically the QMS Quality Event and QualityDocs applications. Experience with working in a hybrid waterfall - iterative methodology is expected by using an incremental, iterative approach to gather and refine scope with solution options before executing a defined and controlled deployment approach using an adaptive, risk-based GxP system change control process.
Responsibilities:
<ul>
<li>Oversees and provides IT support, including vendor operational and maintenance and oversight to the vendor's SLAs for contracted managed services and products.</li>
<li>Prioritize activities and solutions in alignment with overall corporate/business strategies. Review, analyze and evaluate business systems and user needs. Responsible for business systems consulting, project planning, prioritization, and implementation of deliverables, including implementations and operations. Ensures documentation of process and system, functional and business requirements, and objectives for technology initiatives.</li>
<li>IT Technical SME for system activities for system/process enhancements and integration projects. Coordinates support activities across vendor(s) for all support and maintenance and ensures the proper delivery of services, including managed services.</li>
<li>Identifies and troubleshoots technical and system/process issues to resolution.</li>
<li>Represents IT in collaboration with Quality Validation and Business System Owner determine Computer System Validation (CSV) impact and requirements.</li>
</ul>
 o Accountable as the IT System Owner for GxP/CSV solutions. May be called upon to provide evidence of computer system validation and compliance in the case of an audit or inspection.
 o Facilitates and executes IT Computer System Validation activities, including implementation, system release management, and overall support. Computer System Validation and GxP System Change Control documentation may include: System Impact Assessments, Plan(s), Requirements/Specifications, Test Scripts (IQ/OQ/PQ/UAT), Data Migration, Traceability Matrix, Summary Report(s)
Skills &amp; Abilities:
<ul>
<li>Ability to communicate and work independently with cross-functional/inter-departmental teams and within the framework of the IT organization.</li>
<li>Must be able to effectively prioritize and plan; must have the ability to address multiple projects and adapt to changing priorities and ensure.</li>
<li>Self-motivated and passionate to learn and adopt new technology and nimble, pragmatic methodologies. Must be able deal with ambiguity, work through issues with agility but without compromise to best practice processes and documentation.</li>
<li>Team-oriented and generous in sharing knowledge and enabling others</li>
<li>Strong communication and facilitation skills to lead teams to establish consensus, ensure clarity and decisions/justifications</li>
</ul>
Required Work Experience:
<ul>
<li>Experience supporting outsourced partner/vendor organizations.</li>
<li>Experience working in a GxP regulated environment; Computer Software Validation (CSV), and IT SDLC</li>
<li>Degree in computer science, technology, operations, or related disciplines preferred.</li>
<li>5-7+ years pharmaceutical/biotech required</li>
</ul>
Required Technical Knowledge/Experience:
<ul>
<li>Strong understanding and working knowledge of: GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11. ISO Standards including IDMP</li>
<li>Experience with related Technology Solutions/Platforms, including Veeva Vault Quality (QDocs &amp; QMS); Microsoft SharePoint 0365; UL ComplianceWire</li>
<li>Veeva Vault Quality Certified Administrator certification is highly desirable</li>
</ul>
Benefits and Perks:
Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit <a href="https://apellis.com/careers/" target="_blank">https://apellis.com/careers/</a> to learn more. Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information, please visit <a href="http://apellis.com" target="_blank">http://apellis.com</a> or follow us on Twitter and LinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. 
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

IT Business Systems Manager - Quality Systems

<h3>Job Description</h3>
Job Description
The Quality Manager role will work with the GDP Operational QA Management team to ensure that medicines are distributed globally in compliance with GDP and GMP requirements. The Quality Manager will manage the day-to-day Quality oversight of the Third Party Logistics providers and provide support for key stakeholders.
Responsibilities:
<ul>
<li>Support the logistical operations up until the Third Party Logistics providers :</li>
<ul>
<li>Preparation and maintenance of Quality Agreements</li>
<li>Review of deviations, CAPA and changes</li>
<li>Maintaining KPIs</li>
<li>Analyze, resolve, or assist in solving compliance and customer issues.</li>
<li>Escalation of issues</li>
</ul>
<li>Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS</li>
<li>Support strategic Global Logistic transport and storage projects .</li>
<li>Work collaboratively with key internal and external stakeholders</li>
<ul>
<li>Maintain QMS within the Pharmaceuticals Incorporated.</li>
<li>Ensure distribution licences (where required) accurately reflect the current organization, vary liscence where necessary</li>
<li>Support recalls, mock recalls and any other on-market activity.</li>
<li>Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.</li>
<li>Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.</li>
<li>Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.</li>
<li>Planning/ Preparation/supporting/hosting for Regulatory inspections</li>
<li>Providing front and backroom inspection support</li>
<li>Post inspection follow-up with responses and CAPAs (Continuous improvements)</li>
<li>Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)</li>
<li>Manage CAPAs and Effectiveness Checks</li>
<li>Perform other duties as per GDP guidelines and procedures</li>
</ul>
<ul>
<ul>
<li>Work with Product Complaints team to ensure that customer complaints are dealt with effectively.</li>
<li>Ensure that customers and suppliers are approved</li>
<li>Approving any subcontracting activities that may impact GDP.</li>
<li>Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.</li>
<li>Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.</li>
<li>Ensure that any additional requirements imposed on certain products by national law are adhered to.</li>
</ul>
<li>Create/review and approve Standard operating Procedures and other Quality Documents</li>
</ul>
</ul>
Requirements
Qualifications:
<ul>
<li>Bachelor's in a scientific or allied health field and relevant GDP &amp; GMP work experience, or relevant comparable background.</li>
<li>5+ years’ experience serving in a Quality role.</li>
<li>Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.</li>
<li>Influencing skills in areas with no direct reporting authority.</li>
<li>Strong interpersonal and communication skills.</li>
<li>Auditing skills, appropriate qualifications in auditing an advantage.</li>
<li>Fluency in English is required</li>
<li>Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint</li>
</ul>

GDP Operational QA, Quality Manager - Distribution (Contract) 2044

<h3>Job Description</h3>
Job Description
WHO WE ARE 
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. 
THE ROSLINCT WAY 
Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients. 
ACCELERATING YOUR FUTURE 
The Senior QA Specialist – Plant Operations is responsible for providing QA support and expertise in manufacturing plant operations. This includes developing QA specific procedures related to product disposition, line clearance and review and approval of GMP documentation including but not limited to Batch Records, Validation Protocols/Reports, and Calibration/Work Order Records. The ideal candidate has worked in a startup environment with internal manufacturing operations. Specialists will also assist, as required, with product receipt, shipment and disposition, line clearance and quality system review/ approval in the QA role. This is a full time, on-site role at our Hopkinton, MA location. Weekends and holidays may be required. 
How You Will Make an Impact:
<ul>
<li>Develop and implement QA specific procedures required for review and approval of GMP documentation, line clearance, and product disposition</li>
<li>Develop training materials and deliver training for QA specific procedures</li>
<li>Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement</li>
<li>Work cross functionally and provide QA support for development, review and approval of procedures/workflows for manufacturing operations</li>
<li>Provide QA review and approval of plant related SOPs and GMP documentation</li>
<li>Support product disposition and shipping</li>
<li>Support internal audits and GMP readiness </li>
<li>Support Health Authority Inspections and Client Audits</li>
<li>Mentor personnel within QA and cross functionally on GMP compliance, promote quality culture</li>
</ul>
<ul>
<li>Other duties as assigned.</li>
</ul>
What You Will Bring:
<ul>
<li>Add as required</li>
<li>A highly organized work style that ensures timely execution of tasks.</li>
<li>A mindset that ensures accurate results.</li>
<li>Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).</li>
<li>Effective problem-solving capabilities.</li>
<li>Strong oral and written communication skills.</li>
</ul>
Qualifications:
<ul>
<li>5-8 years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing. Cell therapy experience preferred.</li>
<li>Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations. </li>
<li>Prior experience working in contract services and interfacing with clients preferred</li>
<li>Ability to partner cross functionally and provide quality support within agreed timelines to support plant start up activities</li>
<li>Ability to work independently to meet objectives and timelines</li>
<li>Ability to resolve issues and make decisions of moderate complexity independently and escalate complex decisions as needed. </li>
<li>Well versed in cGMP and ICH regulations / guidelines</li>
<li>Strong verbal and written communication skills</li>
</ul>
OUR COMMITMENT
All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. 
RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Sr. QA Specialist - Plant Ops

<h3>Job Description</h3>
Job Description
About Shields Advanced Therapies
Shields Advanced Therapies partners with health systems to accelerate advanced therapy access and operations, ensuring lifechanging breakthroughs reach more patients. Our management services and technology solutions serve as a horizontal support hub to empower health system-led, world-class advanced therapy care across 50+ disease states. Launched in September 2024, Shields Advanced Therapies is anchored by partnerships with four of the Top 20 Academic Medical Centers in the United States. Additionally, Shields' track record partnering with over 1,000 hospitals across 43 states in prior ventures provides a national channel for expansion. 
 
Role Overview
The Accreditation &amp; Quality Specialist plays a central role in ensuring the Advanced Therapy Program maintains compliance with the Foundation for the Accreditation of Cellular Therapy (FACT) standards, as well as institutional, state, and federal regulatory requirements. This position coordinates all aspects of the accreditation process, including document management, quality audits, training compliance, and continuous quality improvement (CQI) initiatives. The specialist will serve as a subject matter expert on FACT standards, liaise with multidisciplinary stakeholders, and drive a culture of excellence and accountability in patient care and product handling.
 
Core Responsibilities
<ul>
<li>
FACT Accreditation &amp; Compliance
<ul>
<li>Lead and coordinate the preparation, submission, and maintenance of FACT accreditation for applicable services (e.g., hematopoietic cell transplantation, immune effector cell therapy, processing lab)</li>
<li>Maintain detailed documentation to demonstrate ongoing compliance with FACT standards</li>
<li>Develop, revise, and manage standard operating procedures (SOPs), policies, and documentation as required by FACT and internal governance</li>
<li>Collaborate with clinical, laboratory, and administrative teams to prepare for FACT inspections and address corrective actions or deficiencies</li>
</ul>
Quality Program Coordination
<ul>
<li>Support and monitor the program's quality management plan, including the collection and review of quality indicators and adverse event tracking</li>
<li>Coordinate regular Quality Management Committee meetings, including agenda preparation, minute taking, and follow-up on action items</li>
<li>Maintain training documentation and ensure staff competencies are up to date in accordance with regulatory and accrediting body requirements</li>
<li>Assist in the identification and implementation of continuous quality improvement (CQI) initiatives</li>
</ul>
Audit &amp; Inspection Readiness
<ul>
<li>Lead internal audits and mock inspections to assess readiness and identify gaps</li>
<li>Serve as a point of contact and escort during external FACT inspections and audits</li>
<li>Compile and maintain evidence binders, document logs, CAPA (corrective and preventative action) responses, and timelines for accreditation and re-accreditation activities</li>
</ul>
Regulatory Alignment &amp; Support
<ul>
<li>Ensure alignment with additional regulatory requirements from agencies such as the FDA, AABB, CLIA, CAP, and state boards</li>
<li>Stay current with updates to FACT standards and applicable federal/state regulations; educate staff on relevant changes</li>
</ul>
</li>
</ul>
Location
Hybrid (Boston, MA &amp; Remote)
 
Experience
<ul>
<li>
<ul>
<li>Registered Nurse - MA</li>
<li>Bachelor's degree in healthcare, life sciences, public health, quality management, or a related field</li>
<li>Minimum 2-4 years of experience in healthcare quality, regulatory compliance, or accreditation-preferably in a cellular therapy, BMT, or laboratory environment</li>
<li>Demonstrated knowledge of FACT standards and accreditation processes</li>
<li>Strong organizational and documentation skills; proficiency in Microsoft Office Suite</li>
</ul>
</li>
</ul>
 
Compensation
<ul>
<li>Competitive base salary with bonus opportunity tied to outcomes metrics.</li>
</ul>
 Job Posted by ApplicantPro

Accreditation & Quality Specialist

<h3>Job Description</h3>
Job Description
Who We Are: 
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. 
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. 
Role Overview:
The Quality Assurance Manager is responsible for leading the Veranova Quality Assurance team, managing quality oversight of the manufacturing process and operations. This includes leading and managing multiple QA teams for batch record review, batch disposition, and on the floor QA support to ensure GMP compliance across all stages of manufacturing, as well as disposition and release of starting materials and customer facing Quality program leads for each client. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards. The role is expected to build strong collaborative relationships with internal and external stakeholders to drive compliance and continuous improvement of GMP operations.
Core Responsibilities: 
<ul>
<li>Lead QA program and create a positive working culture by empowering others. </li>
<li>Define operational excellence locally to align with global objectives. Lead and influence teams of people internally and externally to meet site objectives. </li>
<li>Build and strengthen Veranova’s quality culture and compliance reputation through functional excellence and involvement in organizational forums.</li>
<li>Provide talent development and mentorship. Manage and provide guidance to the QA team supporting GMP manufacturing activities, batch record review, and batch release.</li>
<li>Provide quality expertise, and oversight of manufacturing processes across shift operations to ensure adherence to GMP standards.</li>
<li>Evaluate complex quality or multi-disciplinary situations and make decisions utilizing risk-based approach. Oversight of CDMO performance to compliance and Quality Agreement expectations. </li>
<li>Responsible for Quality oversight to support the manufacturing and release of products, ensuring these activities are timely, efficient and productive while adhering to client’s requirements and operational and quality parameters.</li>
<li>Ensure timely and effective communication with clients on Quality topics, addressing any concerns and providing updates on ongoing quality issues or regulatory matters.</li>
<li>Support the development / amendment of Quality Assurance Agreements with clients, GMP vendors and key raw material suppliers.</li>
<li>Review and approve controlled documents, including deviation, change control, CAPA reports, batch records, SOPs, and product and material specifications.</li>
<li>Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).</li>
<li>Developing, trending, and reporting relevant Quality Metrics associated with the area of responsibility.</li>
<li>Build improved efficiencies by partnering with functional Leaders and Quality having a consistent presence on the floor.</li>
<li>Ensure adequate Quality resources are in place to meet all business functions, working proactively and reactively to meet business demands. </li>
<li>Maintaining the QA Operations function in a state of compliance and Inspection readiness and participate in the support or leading of client audits and regulatory inspections.</li>
<li>Other duties as assigned. </li>
</ul>
Qualifications: 
Required
<ul>
<li>Minimum 11 years of quality assurance experience with an undergraduate degree in engineering, science or related field or minimum 9 years of quality assurance experience with a graduate degree in engineering, science or related field</li>
<li>Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry</li>
<li>Previous people management and/or team leadership experience </li>
<li>Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements</li>
<li>Working knowledge of US &amp; EU GMP, ICH Q7 and Part 11 compliance</li>
<li>Experience with project management and gap assessment projects </li>
<li>Experience creating metrics for driving continuous improvement</li>
<li>Excellent analytical, written and verbal communication and presentation skills</li>
<li>Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks</li>
<li>Proven experience working effectively in team situations and as an individual contributor</li>
<li>Demonstrated behavior that models the Veranova culture to achieve an inclusive environment and exceptional business results</li>
<li>Excellent communication and interpersonal skills with the ability to lead, manage and develop cross-functional relationships.</li>
<li>Analytical mindset with a strong attention to detail and problem-solving skills</li>
<li>Demonstrated networking and influencing skills; ability to collaborate and influence effectively across a broad range of associates spanning varied disciplines and responsibilities</li>
<li>A mindset that promotes a positive work culture.</li>
</ul>
Preferred
<ul>
<li>Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc. </li>
</ul>
Our Commitment:
<ul>
<li>Health &amp; Wellness: Comprehensive health &amp; Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. </li>
<li>Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.</li>
<li>Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.</li>
<li>Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.</li>
</ul>
How to Apply: 
At Veranova, we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit <a href="http://www.veranova.com" target="_blank">www.veranova.com</a> to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise. 
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed. 
If you are a veteran, first responder, or in the process of transitioning from service member to civilian life, we encourage you to apply. Your experience brings invaluable skills and insights that can contribute to our team.
For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to <a href="mailto:talentacquisition@veranova.com" target="_blank">talentacquisition@veranova.com</a> in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. 
Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.
<ul>
<li>Legitimate communications from Veranova will only come from official email addresses using our domain: @veranova.com.</li>
<li>Legitimate LinkedIn communications will only come from active Veranova employees.</li>
<li>Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).</li>
<li>Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).</li>
</ul>
If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: <a href="mailto:pharm.hr@veranova.com" target="_blank">pharm.hr@veranova.com</a> (US) or <a href="mailto:UKHR@veranova.com" target="_blank">UKHR@veranova.com</a> (UK).
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

Associate Director, Quality Assurance - CDMO /GMP Manufacturing

<h3>Job Description</h3>
Job Description
POSITION SUMMARY:
The Quality Assurance Manager oversees the quality management system (QMS) and ensures compliance with AS9100 and other regulations as appropriate. This facility manufactures parts for the Aerospace and Defense producers. This is an ITAR regulated site. The Quality Assurance Manager Quality Engineering and Inspection teams, manages audits, coordinates corrective actions, and works cross-functionally to ensure that all products meet Tecomet’s quality standards. The role is critical in maintaining Tecomet’s quality reputation, improving processes, reducing compliance cost, and ensuring the safety and effectiveness of every product.
ESSENTIAL DUTIES and RESPONSIBILITIES: 
<ul>
<li>Develop and maintain customer relationships; customers are mostly from the US government working in the Aerospace and Defense departments.</li>
<li>Coach and provide training for Quality Engineers and Inspectors while projecting a positive and professional image of the company and of management to employees at all levels;</li>
<li>Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs;</li>
<li>Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans;</li>
<li>Coordinate internal and external audits (customer, supplier, regulatory, and third-party) to assess compliance and identify areas for improvement;</li>
<li>Review and Approve Documentation: Ensure the accuracy and completeness of all quality-related documentation, including SOPs, work instructions, batch records, and validation protocols;</li>
<li>Develop and Implement Corrective and Preventive Actions to identify and address nonconformances, trends, and quality issues by managing CAPA systems and driving continuous improvements;</li>
<li>Stay current with evolving regulations and standards to ensure that company practices are in compliance;</li>
<li>Oversee supplier qualification, audits, and performance monitoring;</li>
</ul>
KNOWLEDGE and SKILLS:
<ul>
<li>Solid understanding of A9100 and other ITAR standards as applicable;</li>
<li>Strong analytical skills with the ability to identify issues and implement solutions;</li>
<li>Excellent written and verbal communication skills;</li>
<li>Above average skills in Microsoft office with the ability to analyze and transform data to display Key Performance Indicators (KPIs) from a variety of data sources;</li>
<li>Proficiency with quality management software and tools (e.g., CAPA systems, audit management software);</li>
<li>Attention to detail and a commitment to maintaining high-quality standards;</li>
</ul>
EDUCATION and EXPERIENCE:
<ul>
<li>Bachelor’s degree in engineering, related field, or equivalent work experience in the Aerospace and defense industry;</li>
<li>5+ years of experience in a quality assurance role within a regulated industry (medical devices preferred);</li>
</ul>
WORK ENVIRONMENT / PHYSICAL DEMANDS:
<ul>
<li>Workers situated in an office environment could routinely use standard office equipment which may include computers, phones, photocopiers, filing cabinets and fax machines;</li>
<li>Workers exposed to the production floor could be frequently exposed to fumes or airborne particles, moving mechanical parts and vibration, and moderate to loud noise conditions;</li>
<li>Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation; </li>
<li>Ability to meet safety, regulatory and health guidelines without assistance;</li>
<li>Ability to maneuver throughout the facility/facilities as needed;</li>
<li>Ability to wear proper Personal Protective Equipment (PPE);</li>
<li>Ability to perform repetitive work; </li>
<li>Standing; walking; manual dexterity sufficient to reach/handle items and work with fingers;</li>
<li>Ability to bend and kneel, loading and unloading work pieces into the machine or moving from one workstation to another; must be able to lift and/or move up to 25 pounds;</li>
<li>Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus;</li>
</ul>
Equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities
Americans with Disabilities Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.

Manager, Quality Assurance

<h3>Job Description</h3>
Job Description
Job Description: 
Perform integration and validation testing activities on software products. Analyzing system and software requirements, and then creating test cases to cover the product requirement. Conduct wide range of system testing, document issues discovered and working with software &amp; system teams to ensure they are equipped with information to resolve the issues.
$ 20.0/hr
Prof23

Test Engineer

<h3>Job Description</h3>
Job Description
JOB DESCRIPTION
Bove’s is seeking a Quality Assurance Manager / SQF Practitioner to join our team! The primary responsibility of this position is to implement, manage and maintain Bove’s Safe Quality Food (SQF) program. The QA Manager works with department managers and staff to ensure daily operations comply with internal procedures and regulatory requirements. Competitive pay based on experience.
Essential Job Functions
· Manage all aspects of product quality and food safety throughout the company to meet FSMA and GFSI requirements such as HACCP, SQF, FSVP certifications.
· Ensure best practice in methods, standards, procedures, and processes are executed throughout production, and facility with regulatory compliance.
· Complete internal inspections for pre-op, GMPs, Food Defense, etc.· Lead regulatory inspections and external audits (SQF, Organic, Non-GMO, GFCO, etc.)
· Develop policies and procedures including GMPs, HACCP, SOPs, Food Safety Plan, pre-requisite programs, process controls, and product specifications.
· Perform validation and verification activities of the SQF/Food Safety, and pre-requisite programs to support program efficacy.
· Evaluate the food safety system to promote continuous improvement.
· Ensure quality policies, procedures, and records are reviewed and updated.
· Manage quality concerns and food safety issues including customer complaints, supplier issues and process deviations.
· Communicate regulatory changes, legislation updates, and deviations to the management team.
· Maintain a positive food safety culture that encourages employee participation.
· Perform routine testing of products, raw materials, processing aids, and environment.
· Review production logs, batch tickets, program forms and maintain records.
· Manage status of Kosher, Gluten-Free, Organic, Non-GMO, and other certifications.
· Perform other related duties, as required.
Qualifications/Basic Job Requirements
· Bachelor’s degree in Food Science, Biology or related field is preferred.
· 3+ years QA/QC experience in FDA or USDA regulated manufacturing site.
· Certifications and training in SQF, HACCP, and PCQI.
· Laboratory testing experience in food industry is preferred.
· Ability to obtain and maintain a valid driver’s license.
· Proficient with Microsoft Office Suite.
· Ability to prioritize and execute tasks independently and in a team setting.
<ul>
<li>Experience in developing food safety plans, HACCP plans, and other programs.</li>
</ul>
· Excellent written and verbal communication skills.
· Excellent analytical and problem-solving skills.
· Excellent interpersonal and customer service skills.
· Excellent organizational skills and attention to detail.
· Excellent time management skills with a proven ability to meet deadlines.
· Ability to function well in a high-paced and at times stressful environment.
·&nbsp;Must be authorized to work in the United States
Physical Requirements
· Prolonged periods sitting at a desk and working on a computer.
· Walking short distances frequently.
· Must be able to lift up to 25 pounds at times.
Benefits
· Medical/Dental Insurance Coverage
· Contributory Retirement Plan
· Paid Sick Leave - After 1 Year of Employment
· Paid Vacation – Two One Week Periods for Planned Factory Shut Downs
· Holiday Pay - Upon Successful Probation Completion
Who We Are –
Est. 1941–&nbsp;From humble beginnings,&nbsp;Bove’s Café opened for business in Burlington, Vermont on December 7th, 1941. After serving the Burlington community for nearly 75 years, we built a state-of the art facility to bottle our restaurant-tested hungry-people-approved pasta sauces. Our experience of going from one neighborhood café to national distribution proved that tried-and-true recipes deserve a tried-and-true production process. And scaling up should never mean letting down the people who got you there.
Join our family –&nbsp;Bove’s continues to be family owned and operated, which allows us to focus on making wholesome and delicious pasta sauces. It also means we understand the importance of family, because we wouldn’t be where we are today without the family, friends and community that have continuously supported us through the years. We are looking for passionate individuals to join our team, who want to be a part of our continuing heritage so we can reach dinner tables across the country.
Additional Information
Bove's of Vermont is proud to be an equal opportunity employer, and we are strongly committed to creating a dynamic and equitable work-force. We do not discriminate on the basis of political or religious affiliation, race, color, national origin, place of birth, ancestry, age, sex, sexual orientation, gender identity, marital status, crime victim status, veteran status, disability, HIV positive status, or genetic information in employment or any other characteristic protected by applicable federal, state, or local laws and ordinances. For accessibility information or alternative formats, please contact Human Resources Department.&nbsp;Reference Bove's Employee Handbook for current benefit offerings and restrictions.
Schedule:
<ul>
<li>10 hour shift</li>
<li>4x10</li>
<li>Day shift</li>
<li>No weekends</li>
</ul>
Shift availability:
<ul>
<li>Day Shift (Required)</li>
</ul>
Ability to Commute:
<ul>
<li>Milton, VT 05468 (Required)</li>
</ul>
Ability to Relocate:
<ul>
<li>Milton, VT 05468: Relocate before starting work (Required)</li>
</ul>
Work Location: In person
Job Type: Full-time
Application Question(s):
<ul>
<li>Are you certified in HACCP, HARCP or PCQI?</li>
<li>Do you have experience representing or supporting a company during third party audits?</li>
</ul>
Work Location: In person

SQF Practitioner / QA Manager

<h3>Job Description</h3>
Job Description
We are seeking a seasoned QA Project Specialist with a strong background in quality remediation, CAPA management, and regulatory compliance to support strategic quality improvement initiatives across the organization. This role is pivotal in driving timely resolution of compliance gaps, ensuring robust root cause analysis, and implementing sustainable corrective and preventive actions (CAPAs). The ideal candidate will have 6+ years of experience in pharmaceutical Quality Assurance with a focus on GxP environments and regulatory remediation activities.
Key Responsibilities:
<ul>
<li>Lead and coordinate remediation projects arising from regulatory inspections, internal audits, or quality system deficiencies.</li>
<li>Manage the full lifecycle of CAPAs: initiation, investigation, root cause analysis (RCA), effectiveness checks, and closure.</li>
<li>Drive cross-functional collaboration to ensure timely and effective execution of quality improvement plans.</li>
<li>Prepare, track, and communicate progress of remediation efforts and CAPA activities to senior QA leadership and regulatory agencies, as needed.</li>
<li>Analyze quality system data to identify trends and areas for proactive improvement.</li>
<li>Support inspection readiness and actively participate in internal and external audits.</li>
<li>Review and enhance quality system procedures and documentation to ensure compliance with FDA, EMA, and other global regulatory standards.</li>
<li>Provide training and guidance to stakeholders on CAPA best practices, deviation handling, and remediation strategies.</li>
<li>Support change control processes related to quality system updates and remediation plans.</li>
</ul>
Requirements
<ul>
<li>Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Chemistry, Biology) or equivalent experience.</li>
<li>Minimum 6 years of Quality Assurance experience in the pharmaceutical, biotech, or regulated life sciences industry.</li>
<li>Demonstrated expertise in CAPA management, root cause analysis methodologies (e.g., 5 Whys, Fishbone, FMEA), and remediation planning.</li>
<li>In-depth knowledge of GxP regulations and quality systems compliance (21 CFR Parts 210/211/820, ICH Q10).</li>
<li>Strong project management skills with the ability to coordinate multiple stakeholders and deadlines.</li>
<li>Experience with electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, or MasterControl.</li>
<li>Experience managing responses to FDA Form 483 observations or Warning Letters.</li>
<li>Familiarity with quality improvement frameworks (e.g., Lean, Six Sigma) is a plus.</li>
<li>Advanced degree or certifications in quality, regulatory affairs, or project management (e.g., PMP, CQE) preferred.</li>
</ul>
Benefits
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
<ul>
<li>Health Care Plan (Medical, Dental &amp; Vision)</li>
<li>Retirement Plan (401k)</li>
<li>Life Insurance (Basic, Voluntary &amp; AD&amp;D)</li>
</ul>

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