Job Description
We are seeking a detail-oriented and experienced Quality Operations Associate to join our team. This role is critical to maintaining the integrity, accuracy, and compliance of our documentation processes and support day-to-day Quality Operations. The ideal candidate will serve as the administrator of our document management system, with a strong preference for expertise in MasterControl Quality Management System (QMS). The candidate will work cross-functionally with every department within the company.
Location: This role will be located in both Walpole, MA (3 days) and Needham, MA (2 days) at Evolved By Nature.
Key Responsibilities:
- Serve as the primary administrator for the document management system, ensuring proper configuration, user access, and system maintenance.
- Manage the creation, revision, approval, distribution, and archival of controlled documents in compliance with internal procedures and regulatory requirements.
- Support internal and external audits by providing timely access to documentation and ensuring records are complete and accurate.
- Train and support users on document control procedures and system usage, especially within MasterControl.
- Collaborate with cross-functional teams to ensure documentation supports business and compliance needs.
- Manage company-wide training and documentation of training for all procedures
- Monitor document lifecycle and ensure timely reviews and updates.
- Generate reports and metrics related to document control activities and system performance.
- Maintain compliance with FDA, ISO, and other applicable regulatory standards.
- Manage the calibration program to ensure equipment is properly maintained and compliant.
- Support the complaint review process by coordinating documentation and quality assessments.
- Provide systematic and QA review support to overseas manufacturing facilities.
- Support QA team by performing other duties, including (but not limited to):
- incoming raw material inspections (e.g., matching COAs to specs)
- conducting first article inspections
- CAPA Board support
- Management Review activities support
- Good Documentation Practices support (e.g., training, doc reviews)
- IQ/OQ/PQ support, as needed
Qualifications:
- Minimum of 5+ years of experience as an administrator of a document management Quality Management System (QMS).
- Hands-on experience with MasterControl QMS is preferred.
- Strong understanding of document control principles, regulatory requirements, and quality system standards.
- Excellent organizational skills and attention to detail.
- Proficient in Microsoft Office Suite and other relevant software tools.
- Strong communication and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
Preferred Qualifications:
- Familiarity with electronic signature workflows and validation requirements.
- Bachelor’s degree in a related field (e.g., Quality, Regulatory, Life Sciences, Business).
- Experience supporting FDA audits or ISO certifications.
Evolved By Nature is a chemical technology company creating new molecules for a more sustainable future. We believe that the next generation of products will advance the health of people and the planet. We have developed molecules from our Activated Silk(tm) technology to create natural, higher performing ingredients that raise the quality and reduce the footprint of the products we need and love. Science meets commerce at our new home, a cutting-edge facility featuring state-of-the-art chemical laboratories, a contemporary wellness center, and creative marketing studio. To learn more about who we are, what we make, and where we work, visit www.evolvedbynature.com