field_job_occupational_field_parents_all

field_job_employment_type

job_organization_name

city

state

<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 Sr. Quality Systems Specialist is a position responsible for supporting the development, implementation, and on-going management of the Quality Management System, as well as supporting software and computer system implementation and integration. The ideal candidate is experienced in Computer System Validation and Software QA including GAMP 5 Software Development Lifecycle. All levels encouraged to apply.
How You Will Make an Impact:
· Provide expertise on the implementation and maintenance of a Quality Management System (QMS), including but not limited to Deviation, CAPA, Change Control, Document Control, Training, Audits and Inspections.
· Identify and drive improvements and standardization of the Quality Management System
· Perform review/approval of Computer System Validation deliverables
· Support CAPA and Change Control implementation
· Monitor implementation of systems ensuring compliance to SOPs and identifying areas for improvement
· Support review and approval of controlled documents
· Support regulatory inspections and client audits
· Support reporting of KPIs as part of Quality Management Review
· Other duties as assigned.
What You Will Bring:
· Effective problem-solving capabilities.
· Strong oral and written communication skills.
· A highly organized work style that ensures timely execution of tasks.
· A mindset that ensures accurate results.
· Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Qualifications:
· 5-8+ years relevant Quality Assurance experience in a pharma/biotech company working within a Quality System, regulated GMP environment and/or computer-related system evaluation / validation. Cell therapy experience a plus.
· Prior experience with implementing and/or executing quality systems, serving as Quality reviewer/approver, and/or continuous improvement initiatives focused on quality systems
· Ability to partner cross functionally and integrate feedback with quality systems
· Ability to work independently to meet objectives and timelines
· Has an awareness of GAMP-5, cGMP and ICH regulations/ guidelines
· Bachelor’s degree in related discipline.
*This is an on-site position with the opportunity for some remote work.
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. Quality Systems Specialist

<h3>Job Description</h3>
Job Description
Title: Quality Assurance Manager 
Department: Ops Engineering
Revision Date: 5/12/2025
Location: Annapolis, MD or Stoughton, MA, or Topsfield, MA (Preferred in EST)
Level: T4
Rate of Pay: $118,000 - $160,000 USD
Company Overview
Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud-native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions. For more information, please visit <a href="http://www.comtech.com" target="_blank">www.comtech.com</a>. 
Position summary:
The Quality Specialist is committed to achieving and maintaining the highest standards of quality across Comtech business, operations, products and services. The Quality Specialist role is vital to ensuring that Comtech products and services meet ISO 27001: 2022, NIST 800-53 r5, ISO &amp; TL 9000 Quality standards and guidelines. This position requires a dynamic individual with a keen eye for detail, strong organizational skills, and a passion for continuous improvement. Functions include analyzing and optimizing processes across various areas of the company, identifying trends for areas of improvement, drafting comprehensive quality reports, and educating team members on quality protocols. This role must maintain a desire to influence quality from the ground up and thrive in a dynamic, fast-paced environment.
Responsibilities:
<ul>
<li>Develop and implement quality management systems and processes</li>
<li>Collaborating with various departments to drive initiatives that enhance Comtech Quality objectives</li>
<li>Facilitate regular audits and conductinspections to ensure compliance with quality standards</li>
<li>Prepare and coordinate audit and certification reports with auditors</li>
<li>Collaborate with cross-functional teams to identify and resolve quality issues</li>
<li>Prepare and present reports on quality metrics and performance</li>
<li>Facilitate training sessions for staff on quality standards and procedures</li>
<li>Coordinate with internal/external auditors and regulatory bodies as needed</li>
<li>Maintain documentation related to quality management systems</li>
<li>Implement corrective and preventive actions to address quality issues</li>
<li>Prepare/ authorize Corrective Action Plans for identified audit/ certification gaps</li>
<li>Support continuous improvement initiatives and projects</li>
</ul>
Requirements:
<ul>
<li>Experience with statistical analysis and quality control tools</li>
<li>Proven track record of managing quality improvement projects</li>
<li>Strong analytical and problem-solving skills</li>
<li>Excellent communication and interpersonal skills</li>
<li>Experience in manufacturing or service industry</li>
<li>Proficiency in using quality management software</li>
<li>Ability to facilitate audits and conduct inspections</li>
<li>Strong attention to detail</li>
<li>Experience with business process formation and enhancement </li>
<li>Effective time management and organizational skills</li>
<li>Ability to work independently and as part of a team</li>
</ul>
Qualifications: 
<ul>
<li>Bachelor's degree in Quality Management, Engineering, or related field</li>
<li>Certification in quality management (e.g., Six Sigma, ISO 9001)</li>
<li>Minimum of 3 years of experience in quality management or a related role</li>
<li>Familiarity with Business Process Modeling (e.g., BPMN 2.0)</li>
<li>Experience with quality standards, security frameworks, and regulations (e.g., ISO 27001: 2022, NENA, NIST 800-53 r5, ISO &amp; TL 9000, etc.)</li>
</ul>
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability protected veteran status or other characteristics protected by law.

Manager, Quality Assurance

<h3>Job Description</h3>
Job Description
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. 
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. 
This position is site-based and requires a presence on-site five days per week. 
Summary
Quality Assurance Specialist who, under minimal supervision, provides Quality oversight activities for the aseptic fill/finish manufacturing suite, Quality Control and technical organization to ensure manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP regulations marketed products and/or their raw materials, APIs, excipients or components.
Key Responsibilities/Essential Functions
<ul>
<li>Provide technical expertise in conducting investigations and making recommendations for targeted data and information collection for quality event review and closure.</li>
<li>Collaborate with cross-functional production support teams to identify root cause and determine appropriate corrective action/preventative actions for investigations.</li>
<li>Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.</li>
<li>Review and approve protocols, validation documents, investigations and procedures.</li>
<li>Approve change controls and represent Quality in Change Control Board meetings as needed.</li>
<li>Provide Quality on the floor presence in support of manufacturing operations.</li>
<li>Represent QA in a range of internal team meetings, processes and initiatives.</li>
<li>Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.</li>
<li>Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety &amp; environmental hazards.</li>
<li>Actively demonstrates the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.</li>
<li>* In the case of absence, reports to Manager above or a peer incumbent will function as a backup for this position.</li>
</ul>
Basic Qualifications 
<ul>
<li>BS/BA degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.</li>
<li>This position is site-based and requires a presence on-site five days per week.</li>
</ul>
Other Requirements
<ul>
<li>Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.</li>
<li>Routinely scheduled work, and/or work required on evenings, weekends, and or holidays and, even in adverse weather conditions to support manufacturing operations. See Essential Personnel Policy.</li>
<li>Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.</li>
<li>Ability to travel up to 10% domestically.</li>
</ul>
Core Values
The ideal candidate will embody Lantheus core values:
<ul>
<li>Let people be their best</li>
<li>Respect one another and act as one</li>
<li>Learn, adapt, and win</li>
<li>Know someone’s health is in our hands</li>
<li>Own the solution and make it happen</li>
</ul>
Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at <a href="mailto:talentacquisition@lantheus.com" target="_blank">talentacquisition@lantheus.com</a>.

Quality Assurance Specialist

<h3>Job Description</h3>
Job Description
🚗 Why us? 
<ul>
<li>
Join a pre-IPO startup with capital, traction and runway ($240M funded | 60X revenue growth in 5 years | $2T+ market size)
</li>
<li>
2024 was a milestone year for Jerry.ai. We delivered nearly 60X revenue growth in 5 years while reaching profitability for the first time in our history
</li>
<li>
Work closely with brilliant leaders and teammates from companies like NVIDIA, Robinhood, Amazon, Meta, ByteDance, Square, and more
</li>
<li>
Opportunity to take us to a $10B business and a household name in the next few years
</li>
<li>
Our growth is driven by forward-thinking technology; Harvard Business Review covered the success of our chatbot less than a year after its launch and Jerry.ai is getting mentioned in many conversations about about our use of GenAI, such as this Forbes article
</li>
<li>
Be immersed in a talent-dense environment, greatly accelerate your learning and career growth
</li>
</ul>
&amp;#x1F4BB; About the opportunity
At Jerry.ai, we've redefined car ownership through our innovative digital solutions. Now, we're expanding our horizons with Propelix, our exciting new subsidiary focused on creating a SaaS platform that makes it easy to build and test advanced chatbots and voice bots.
 We're seeking a purpose-driven Senior Engineer to join our innovative Chatbot Team at Propelix, where you'll be at the forefront of developing a platform that empowers businesses to create, deploy, and optimize AI-powered conversation solutions without extensive technical expertise. This role offers a unique opportunity to fully participate in every phase of product development - from user communication and requirements gathering to development and deployment. You won't just execute tasks; you'll contribute as a product designer and planner while experiencing our vibrant geek culture.
🫵 How you will make an impact
<ul>
<li>
Develop new features for our chatbot/voicebot SaaS platform while maintaining high-quality engineering standards
</li>
<li>
Build tools that simplify chatbot creation, testing, and optimization for our clients
</li>
<li>
Collaborate with product managers and designers to enhance the user experience for non-technical customers
</li>
<li>
Apply your understanding of LLM functionality to optimize conversation flows and responses
</li>
<li>
Help shape the future of Propelix as a leading SaaS solution in the conversational AI space
</li>
<li>
Support junior engineers and foster a culture of continuous learning
</li>
</ul>
🚀 Requirements
<ul>
<li>
6+ years of full-time software development experience with a bachelor's degree or higher in computer science or engineering
</li>
<li>
Knowledge of multiple programming languages (we primarily use JavaScript, React, Node.js - knowledge of these in particular not required)
</li>
<li>
Familiarity with cloud infrastructure (AWS, Azure)
</li>
<li>
Experience with distributed systems or large-scale web applications
</li>
<li>
Startup experience at a high-growth company (nice to have)
</li>
</ul>
Bonus points for LLM experience, CI/CD knowledge, React Native proficiency, and open-source contributions!
Our tech stack 
<ul>
<li>
React for web frontend
</li>
<li>
NodeJS + Typescript for backend development
</li>
<li>
React (mobile app is written in React Native)&nbsp;
</li>
<li>
Hosting infra: AWS
</li>
<li>
SMS: Twilio
</li>
<li>
Push notification: APNS and FCM
</li>
</ul>
While we appreciate your interest and application, only applicants under consideration will be contacted.
Jerry.ai is proud to be an Equal Employment Opportunity employer. We prohibit discrimination based on race, religion, color, national origin, sex, pregnancy, reproductive health decisions or related medical conditions, sexual orientation, gender identity, gender expression, age, veteran status, disability, genetic information, or other characteristics protected by applicable local, state or federal laws. 
Jerry.ai is committed to providing reasonable accommodations for individuals with disabilities in our job application process. If you need assistance or an accommodation due to a disability, please contact us at <a href="mailto:recruiting@jerry.ai" target="_blank">recruiting@jerry.ai</a>
About Jerry.ai:
Jerry.ai is America’s first and only super app to radically simplify car ownership. We are redefining how people manage owning a car, one of their most expensive and time-consuming assets.&nbsp;
Backed by artificial intelligence and machine learning, Jerry.ai simplifies and automates owning and maintaining a car while providing personalized services for all car owners' needs. We spend every day innovating and improving our AI-powered app to provide the best possible experience for our customers. From car insurance and financing to maintenance and safety, Jerry.ai does it all.
We are the #1 rated and most downloaded app in our category with a 4.7 star rating in the App Store. We have more than 5 million customers — and we’re just getting started.&nbsp;
Jerry.ai was founded in 2017 by serial entrepreneurs and has raised more than $240 million in financing.
Join our team and work with passionate, curious and egoless people who love solving real-world problems. Help us build a revolutionary product that’s disrupting a massive market.

Senior Full Stack Engineer

Senior Software Engineer - Conversational AI

<h3>Job Description</h3>
Job Description
JOB SUMMARY:
The Quality Systems Manager will provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. The role requires the above to be accomplished within Tecomet principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
<ul>
<li>Oversee and implement an advanced level of world-class quality systems for planning, design of experiments (DOE), ISO 13485, quality function development (QFD), design for world-class manufacturability. </li>
<li>Take a leadership role and mentor supporting functional team members.</li>
<li>Integrate the quality function with manufacturing as a value added (real-time) support function, optimizing the continuous quality improvement process, while reducing cost and improving customer relationships.</li>
<li>Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity and maximize the profit margins for Tecomet. The objective is to devise systems that facilitate good products fast without compromise.</li>
<li>Assure Tecomet is conducting business within compliance to the regulations, as cost effectively and efficiently as possible.</li>
<li>Provide organizational assessments to upper management.</li>
<li>Enhance company systems interface capabilities while optimizing the capabilities to perpetuate harmonized systems improvements through deployment of best practices from the collective experience contribution of the worldwide teams.</li>
<li>Focus on continual quality improvement, while aligned with internal and external customer expectations. The results/objectives are geared on achieving an error-free (flawless) process, which will deliver products on time with world-class quality standards for improving quality, profits and generating new business.</li>
<li>Ensure the organization is basing improvement related decisions on factually/meaningful data, subsequently reducing waste and expediting the recognition of favorable results.</li>
<li>Leadership responsibility for promoting and developing the Tecomet Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.</li>
<li>Performs other duties or special projects as required or as assigned by supervisor. </li>
</ul>
KNOWLEDGE, SKILLS AND ABILITIES:
<ul>
<li>Strong organizational skills</li>
<li>Strong people and leadership skills</li>
<li>Diplomacy</li>
<li>Motivation</li>
<li>Teaching/Coaching/Mentoring</li>
<li>Verbal and written communication and listening skills</li>
<li>Highly Proficient in Microsoft Office</li>
<li>Problem solving and evaluation</li>
<li>Process improvement</li>
<li>Project management</li>
<li>ISO 13485/EN46001</li>
<li>ISO 14001</li>
<li>Federal and State laws and regulations</li>
<li>Knowledge of International Quality Standards</li>
<li>Strong auditing background</li>
<li>Speak in front of people in a variety of settings</li>
<li>Be flexible and adapt to changes in the marketplace</li>
<li>Create and manage high performing work teams</li>
<li>Interface professionally and courteously with customers/public/internal staff</li>
<li>Meet goals and objectives set for the company</li>
<li>Make decisions in a consistent, professional manner</li>
<li>Maximize opportunities for the business</li>
</ul>
EDUCATION AND WORK EXPERIENCE:
Educational/Training Requirement: 
<ul>
<li>Bachelor of Science in Engineering (ME, IE, BME), preferred</li>
<li>Experience, training and certification may be considered</li>
<li>Master’s degree (desirable but not essential)</li>
</ul>
Experience: 
<ul>
<li>5+ years of Quality Engineering experience within a manufacturing environment required.</li>
<li>Minimum of 2 years of experience related to working within a regulated environment is preferred.</li>
<li>3-5 years working directly with New Product Development and/or related launches, preferred.</li>
</ul>
Licenses/Certifications: 
<ul>
<li>Six Sigma Black Belt certification (desirable but not essential)</li>
<li>ASQ: CBA, CQA and CQE certification, preferred.</li>
</ul>
PHYSICAL AND ENVIRONMENTAL DEMANDS:
<ul>
<li>Mobility to move throughout the production facilities and various sites, and to sit for eight (8) or more hours per day.</li>
<li>Able to communicate quickly and clearly verbally, in writing and by phone.</li>
<li>Able to perform repetitive, highly accurate keyboard operations for eight(8) or more hours per day and on weekends (if required)</li>
<li>Ability to read fine print</li>
<li>Position takes place in a well-lighted, heated/air-conditioned indoor office/production setting with adequate ventilation</li>
<li>Light physical activity performing non-strenuous daily activities of a primarily administrative nature.</li>
<li>Manual dexterity sufficient to reach/handle items and work with fingers </li>
<li>Ability to wear proper PPE. TRAVEL REQUIREMENTS: X YES NO 
<ul>
<li>Travel will be determined as needed.</li>
</ul>
</li>
</ul>
Americans with Disabilities Act (ADA): 
<ul>
<li>Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. </li>
</ul>
Equal Opportunity/Affirmative Action Employer/Protected/ Veterans/Disabilities/Drug Free Workplace

Manager, Quality Systems

<h3>Job Description</h3>
Job Description
CodaMetrix (CMX) is revolutionizing Revenue Cycle Management with its AI-powered autonomous coding solution, a multi-specialty AI-platform that translates clinical information into accurate sets of medical codes. CodaMetrix’s&nbsp; autonomous coding drives efficiency under fee-for-service and value-based care models and supports improved patient care. We are passionate about getting physicians and healthcare providers away from the keyboard and back to clinical care. Overview
The Vice President, Data Platforms is a member of the Data &amp; Analytics team, reporting to the Senior Vice President, Data &amp; Analytics. The Data &amp; Analytics team consists of the Data Engineering, Business Intelligence, Customer Integrations and Data Analysis teams and is responsible for supporting all internal teams who consume data on a regular basis (Engineering, Machine Learning, Analytics, etc. and developing data products for CMX customers. The goal of the team is to develop and execute on the Data &amp; Analytics strategy.
The Vice President, Data Platforms is responsible for maintaining the health of the Databricks Lakehouse platform and ensuring that all required data is sourced proactively and cost-effectively for CMX Machine Learning teams. They are also accountable for all data ingestion, architecture, engineering and sourcing functions.
Responsibilities
<ul>
<li>Own and evolve the Databricks Data Lake platform strategy, architecture, security, and operations.</li>
<li>Lead all data ingestion ETL/ELT, and data integration activities from internal and external sources.</li>
<li>Architect and oversee scalable data pipelines and services to source and curate high-quality datasets for machine learning, analytics, and business intelligence use cases.</li>
<li>Collaborate closely with machine learning, product, data analysis, integrations and engineering teams to prioritize data needs and ensure data availability, quality, and accessibility.</li>
<li>Build, lead, mentor a high-performing data engineering and data architecture team while establishing a robust sourcing function for machine learning.</li>
<li>Establish data governance, metadata management and data quality frameworks.</li>
<li>Optimize cost, performance, and operational efficiency of the data infrastructure.</li>
<li>Ensure compliance with HIPAA, SOC2, and other healthcare data security standards.</li>
<li>Develop and manage budgets, vendor relationships, and technology evaluations related to the data platform ecosystem.</li>
<li>Partner with senior leadership, including the Architecture committee, to align data platform initiatives with company goals and the product roadmap.</li>
<li>Work closely with engineering managers, machine learning, and implementations teams to understand the current state of data acquisition, processing, storage and usage.</li>
<li>Define, document, and communicate the data management lifecycle to all internal data stakeholders and participate as a key member of the Architecture Review Council.</li>
<li>Contribute as a member of the senior leadership team by driving the data initiatives for the company.</li>
</ul>
&nbsp;Requirements&nbsp;&nbsp;
<ul>
<li>Required
<ul>
<li>10+ years of experience in data engineering, data architecture, or data platform leadership roles with 5+ years leading data platform teams.</li>
<li>Expertise managing and scaling cloud-based data platforms particularly Databricks on AWS or Azure.</li>
<li>Deep experience designing and operating large scale data lakes, real-time and batch data pipelines, and streaming architectures.</li>
<li>Strong understanding of ML and AI data sourcing needs (labeled datasets, feature stores, etc.)</li>
<li>Experience working with structured, semi-structured, and unstructured healthcare data (EHR, claims, clinical notes, HL7, FHIR)&nbsp; is highly desirable.</li>
<li>Strong knowledge of modern data technologies (Spark, Delta Lake, Kafka, Airflow, dbt, etc.)</li>
<li>Solid grasp of data security, privacy, and compliance frameworks (HIPAA, SOC2, HITRUST).</li>
<li>Excellent leadership, collaboration, and communication skills, with the ability to influence across technical and business teams.</li>
<li>Bachelor’s or Master’s degree in Computer Science, Engineering, Information Systems or related field; advanced degree preferred.</li>
</ul>
</li>
<li>Preferred
<ul>
<li>Startup and/or Commercial experience</li>
<li>Healthcare Technology experience</li>
<li>Databricks and/or Snowflake experience​​​​​​​</li>
</ul>
</li>
</ul>
The estimated hiring range for this role is $215,000 - $255,000 (plus applicable bonus/plus equity). This hiring range could vary by region based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
 &nbsp;
What CodaMetrix can offer you: 
Learn more about our full-time employee benefits and how we take care of our team.
<ul>
<li>Health Insurance: We cover 80% of the cost of medical and dental insurance and offer vision insurance</li>
<li>Retirement: We offer a 401(k) plan that eligible employees can contribute to one month after their first day</li>
<li>Flexibility: We have a generous Paid Time Off policy, which is managed but not limited, so you can take the time you need to relax and rejuvenate</li>
<li>Learning: All new hires complete our 7-week Onboarding Program where they learn about our company and each of our departments through live sessions hosted by a variety of our leaders</li>
<li>Development: We provide annual performance evaluations and prioritize working with employees on what their individual growth looks like </li>
<li>Recognition: We recognize the outstanding achievements of our team through annual company awards where employees have the opportunity to nominate their peers</li>
<li>Office Location: A modern open plan workspace located in the bustling Back Bay neighborhood of Boston</li>
<li>Additional Employer Paid Benefits: We offer employer-paid life insurance and short-term and long-term disability insurance</li>
</ul>
Background Check Notice
All candidates will be required to complete a background check upon acceptance of a job offer.
Equal Employment Opportunity
Our company, as well as our products, are made better because we embrace diverse skills, perspectives, and ideas. CodaMetrix is an Equal Employment Opportunity Employer and all qualified applicants will receive consideration for employment.
Don’t meet every requirement? We invite you to apply anyway. Studies have shown that women, communities of color and historically underrepresented talent are less likely to apply to jobs unless they meet every single qualification. At CodaMetrix we are committed to building a diverse, inclusive and authentic workplace and encourage you to consider joining us.
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ZateDhgwSG

Vice President, Data Platforms

<h3>Job Description</h3>
Job DescriptionApply now: QA Complaint Coordinator, Hybrid opportunity local to Bedford, MA. The start date is ASAP for this long-term contract position. Job Title: QA Complaint Coordinator Location: Bedford, MA (3 days/week) Duration: 12 months with opportunity for hire after 6 months Rate: Up to $30/hr W-2 Start Date: ASAP
 Job Summary:
 My client, a leading medical device company, is seeking a dedicated and detail-oriented QA Complaint Coordinator for the postmarket team at a leading medical device company.
 As a Quality Assurance Complaint Coordinator, you will play a crucial role in maintaining and managing the documentation processes for our complaint intake processes. Your meticulous attention to detail and expertise in documentation management will contribute to ensuring compliance with regulatory requirements and quality standards. This position offers an opportunity to work in a fast-paced environment and make a significant impact on patient care.
 Key Responsibilities:
 Document Reviews: Facilitate document reviews by coordinating with subject matter experts, tracking review timelines, and ensuring timely completion of reviews.
 Document Distribution and Training: Manage the distribution of controlled documents, maintain records of document access, and support the training process by ensuring employees are trained on the proper use and understanding of quality documents.
 Document Archiving and Retrieval: Establish and maintain a robust document archiving system to ensure easy retrieval, traceability, and document retention in accordance with regulatory requirements.
 Audit Support: Assist in internal and external audits by providing requested documentation and ensuring all documents are audit-ready.
 Adherence to Regulatory Standards: Stay up-to-date with regulatory requirements, industry trends, and best practices related to document control and quality documentation management.
 Qualifications:
<ul>
<li> Relevant work experience in an administrative capacity, ideally in a medical device company or similar industry</li>
<li> Understanding of quality management systems, document control processes, and regulatory requirements (e.g., FDA, ISO 13485) is a plus</li>
<li> Proficiency in document control software and electronic document management systems.</li>
<li> Excellent organizational skills with exceptional attention to detail.</li>
<li> Strong written and verbal communication skills.</li>
<li> Ability to work independently, manage multiple tasks simultaneously, and meet deadlines.</li>
<li> Collaborative mindset with the ability to work effectively in cross-functional teams.</li>
</ul>

QA Complaint Coordinator

<h3>Job Description</h3>
Job Description
COMPANY DESCRIPTION:
Syner-G Biopharma Group is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market. 
We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality. 
Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide. 
Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation.  
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.  
For more information, visit <a href="http://www.Synergbiopharma.com" target="_blank">www.Synergbiopharma.com</a>
POSITION OVERVIEW:
The Senior Consultant, Quality leads the evaluation of quality events, incidents, and possible complaints and the follow-up of such events. Perform / Lead GMP auditing of manufacturing facilities of clients, vendors, and internal operations as well as ensure that the CMC Quality vertical works seamlessly with Syner-G's Technical group, Regulatory Affairs, CMC leads, and others on the team, as well as key external parties. The Sr Consultant will operate independently, managing day-to-day operations with minimal input or support needed.
WORK LOCATION:
This position is eligible for remote work based on company requirements, with no minimum in-office requirement. Domestic and international travel may be required for this position (Up to 25%).
JOB FUNCTIONS:
(This list is not exhaustive and may be supplemented and changed as necessary.)
<ul>
<li>Work individually and lead others in the Quality business vertical by being the face of the service for Syner-G and our clients.</li>
<li>Collaborate with other business verticals like manufacturing and CMC Technical and Regulatory teams to achieve client needs when appropriate.</li>
<li>Review and approve SOPs, product specifications, batch records, and Annual Product Quality Reports.</li>
<li>Lead / Support development, implementation, and maintenance of the Client's Quality System, including facilitating process improvement activities to the product and project teams for continuous improvement.</li>
<li>Lead / Support Quality System reviews, deviations, OOS, CAPAs, and other remediation plans depending on client needs.</li>
<li>Review the source batch records, COAs, Stability data, and regulatory documentation for the products.</li>
<li>Manage pre-approval inspections by health authorities and internal audits.</li>
<li>Lead / Support building the quality vertical for Syner-G.</li>
<li>Serve as a subject matter expert in areas such as facility cleanroom design, offering guidance and recommendations based on extensive experience.</li>
<li>Act as a liaison between clients and CMOs/Contract labs.</li>
<li>Approve all documents before clinical trials, including creating Certificates of Analysis (COAs) for drug release, expanding accounts from the original Statement of Work (SOW), and providing project components to regulatory bodies such as the FDA.</li>
<li>Possess proficiency in influencing others to achieve objectives, strong problem-solving and critical thinking abilities, comprehensive understanding of all phases of drug development from analytical to manufacturing to commercial, and confidence in leading clients in decision-making processes.</li>
</ul>
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties.
Education:
A bachelor's or advanced degree (e.g., B.S., M.S., Ph.D.) in biology, biochemistry, chemical engineering, or relevant discipline is required.
Technical Experience:
<ul>
<li>2-5+ years FDA field inspection experience.</li>
<li>10+ years of relevant experience in pharmaceutical industry.</li>
<li>Field inspection experience of small and large molecule pharmaceutical/ biotech companies.</li>
<li>Perform cGMP inspections of finished drug facilities, API manufacturers, contract laboratories.</li>
<li>Conduct Pre-Approval Inspections (PAI) of laboratory facilities.</li>
<li>Familiar with FDA/ORA Investigator practices and procedures.</li>
<li>Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required.</li>
<li>Working knowledge of cGxPs, ICH and applicable international regulations and guidelines.</li>
<li>Ability to evaluate and follow-up on quality events, incidents and possible complaints.</li>
<li>Understanding of quality system reviews, deviations, OOS, CAPAs and other remediation plans depending on client needs.</li>
<li>Comprehensive understanding of applicable CFR regulations, Regulatory guidelines, quality standards, ICH guidelines, quality management systems initiatives, and industry-specific regulations.</li>
<li>Understanding of computers systems validation methodologies and related industry expectations.</li>
<li>Ability to support the development, implementation, and maintenance of client quality systems including facilitating process improvement activities to the product and project teams.</li>
<li>Adept at applying risk-based and phase-appropriate quality approaches.</li>
</ul>
Knowledge, Skills, and Abilities:
<ul>
<li>Strong Quality Management System knowledge and skills.</li>
<li>Strong time management skills: ability to work under pressure in a fast-paced environment, to coordinate multiple tasks concurrently, adapt to changing priorities, and to meet deadlines.</li>
<li>Excellent project management skills to effectively organize, prioritize, and plan client deliverables.</li>
<li>Effective relationship-building and client management skills, alongside confidence in decision-making and trust-building.</li>
<li>Ability to be adaptable, flexible and develop creative approaches to meet customer needs and improve customer outcomes.</li>
<li>Exceptional stakeholder management skills with the ability to adapt influencing strategies, articulate compelling solutions, uncover client concerns through insightful questioning, and address objections effectively.</li>
<li>Ability to work independently with minimal supervision and problem solve proactively.</li>
<li>Skilled communicator, both written and verbal, who can present ideas and critical information to clients and internal team members effectively and in a concise, organized, impactful manner.</li>
<li>Strong organizational skills and attention to detail.</li>
<li>Demonstrated leadership and management skills.</li>
<li>Strong critical thinking and problem-solving skills: ability to exercise sound reasoning to analyze issues, make decisions, and overcome problems.</li>
<li>Ability to work effectively within a team environment by encouraging collaboration and exhibiting an interpersonal style that is enthusiastic, approachable, and supportive.</li>
</ul>
ESSENTIAL FUNCTIONS:
Physical Demands:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
TOTAL REWARDS:
We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; Boulder, CO; and Chennai, India.
  
LEGAL STATEMENT: Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.

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