Senior Associate, Quality Assurance
Ocular Therapeutix, Inc.
June 27, 2026
On-site
Bedford, MA
Operations
Position Summary
- The Senior Associate, QA will provide Quality Assurance (QA) oversight for the production of drug products across end-to-end operations (technology transfer through clinical production and commercialization).
- Provide QA oversight of Quality Control (QC) activities to ensure compliance with applicable regulatory requirements (e.g., GMP, GLP) and internal quality standards, supporting product quality, safety, and data integrity.
- Provide quality oversight and phase-appropriate cGMP guidance throughout the product lifecycle.
Principal Duties and Responsibilities
- Provide QA support for site operations, including in-house manufacturing and CDMO activities, and supply chain distribution.
- Provide on-floor support during critical manufacturing processes.
- Support releasing manufacturing suites and batch/product changeovers.
- Participate in cross-functional teams to resolve quality issues impacting operations.
- Review/approve key documentation (MBRs, product specifications, change controls, deviations, CAPAs).
- Participate in Change Control Review Board and provide quality input.
- Perform quality system activities (Change Control, Deviation Reporting, CAPA).
- Author/review/approve internal quality documents (SOPs, investigations, etc.).
- Support QA leadership for compliance and inspection readiness.
- Support Annual Product Review (APR) reporting and process control analysis.
- Review/approve QC documentation (test records, analytical data, logbooks).
- Ensure adherence to SOPs, test methods, and regulations (FDA, EMA, ICH).
- Review/approve Certificates of Analysis (CoA), analytical results/reports, and stability data.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- 5+ years’ experience in pharmaceutical, biotech, or medical device.
- Strong knowledge of GMP and GLP and regulatory expectations.
- Understanding of analytical testing and laboratory workflows.
- Familiarity with OOS investigations, deviations, and CAPA.
- Excellent organizational skills and attention to detail.
- Good verbal and written communication; strong teamwork skills.
- Computer literacy (MS Office, Excel, PowerPoint).
- Ability to make decisions and resolve issues with minimal guidance.
Working Conditions
- Office environment (primary); clean room/manufacturing environment when required.
Salary Range
- $109,000 USD - $121,000 USD
- The Senior Associate, QA will provide Quality Assurance (QA) oversight for the production of drug products across end-to-end operations (technology transfer through clinical production and commercialization).
- Provide QA oversight of Quality Control (QC) activities to ensure compliance with applicable regulatory requirements (e.g., GMP, GLP) and internal quality standards, supporting product quality, safety, and data integrity.
- Provide quality oversight and phase-appropriate cGMP guidance throughout the product lifecycle.
Principal Duties and Responsibilities
- Provide QA support for site operations, including in-house manufacturing and CDMO activities, and supply chain distribution.
- Provide on-floor support during critical manufacturing processes.
- Support releasing manufacturing suites and batch/product changeovers.
- Participate in cross-functional teams to resolve quality issues impacting operations.
- Review/approve key documentation (MBRs, product specifications, change controls, deviations, CAPAs).
- Participate in Change Control Review Board and provide quality input.
- Perform quality system activities (Change Control, Deviation Reporting, CAPA).
- Author/review/approve internal quality documents (SOPs, investigations, etc.).
- Support QA leadership for compliance and inspection readiness.
- Support Annual Product Review (APR) reporting and process control analysis.
- Review/approve QC documentation (test records, analytical data, logbooks).
- Ensure adherence to SOPs, test methods, and regulations (FDA, EMA, ICH).
- Review/approve Certificates of Analysis (CoA), analytical results/reports, and stability data.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- 5+ years’ experience in pharmaceutical, biotech, or medical device.
- Strong knowledge of GMP and GLP and regulatory expectations.
- Understanding of analytical testing and laboratory workflows.
- Familiarity with OOS investigations, deviations, and CAPA.
- Excellent organizational skills and attention to detail.
- Good verbal and written communication; strong teamwork skills.
- Computer literacy (MS Office, Excel, PowerPoint).
- Ability to make decisions and resolve issues with minimal guidance.
Working Conditions
- Office environment (primary); clean room/manufacturing environment when required.
Salary Range
- $109,000 USD - $121,000 USD