Senior Associate, Quality Assurance
Ocular Therapeutix, Inc.
August 22, 2026
On-site
Bedford, MA
Operations
Position Summary
The Senior Associate, QA provides Quality Assurance oversight for production of drug products (end-to-end from technology transfer and clinical production through commercialization) and oversees QC activities to ensure compliance with applicable regulatory requirements (e.g., GMP, GLP) and internal standards. Ensures QC testing, documentation, and data integrity practices support product quality and safety, and provides 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, plus supply chain distribution workflows.
- Provide on-floor support during critical manufacturing processes.
- Release manufacturing suites and batch/product changeovers.
- Participate in cross-functional teams to resolve quality issues.
- Review/approve key documents: MBRs, product specifications, change controls, deviations, CAPAs.
- Participate in Change Control Review Board with quality input.
- Execute quality system activities (Change Control, Deviation Reporting, CAPA).
- Author/review/approve internal quality documents (SOPs, investigations).
- Support inspection readiness and compliance of QA Operations.
- Support Annual Product Review (APR) reports and process control analysis.
- Review/approve QC documentation (test records, analytical data, logbooks).
- Ensure adherence to SOPs, test methods, and regulatory requirements (FDA, EMA, ICH).
- Review/approve CoAs, analytical test results/reports, and stability data.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- 5+ years’ experience in pharma/biotech/medical device.
- Strong knowledge of GMP/GLP and regulatory expectations.
- Understanding of analytical testing and laboratory workflows.
- Familiarity with OOS investigations, deviations, and CAPA processes.
- Excellent organization and attention to detail; strong verbal/written communication.
- Strong interpersonal skills; ability to work on a team.
- 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 as needed.
Salary Range
- $109,000 USD – $121,000 USD
The Senior Associate, QA provides Quality Assurance oversight for production of drug products (end-to-end from technology transfer and clinical production through commercialization) and oversees QC activities to ensure compliance with applicable regulatory requirements (e.g., GMP, GLP) and internal standards. Ensures QC testing, documentation, and data integrity practices support product quality and safety, and provides 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, plus supply chain distribution workflows.
- Provide on-floor support during critical manufacturing processes.
- Release manufacturing suites and batch/product changeovers.
- Participate in cross-functional teams to resolve quality issues.
- Review/approve key documents: MBRs, product specifications, change controls, deviations, CAPAs.
- Participate in Change Control Review Board with quality input.
- Execute quality system activities (Change Control, Deviation Reporting, CAPA).
- Author/review/approve internal quality documents (SOPs, investigations).
- Support inspection readiness and compliance of QA Operations.
- Support Annual Product Review (APR) reports and process control analysis.
- Review/approve QC documentation (test records, analytical data, logbooks).
- Ensure adherence to SOPs, test methods, and regulatory requirements (FDA, EMA, ICH).
- Review/approve CoAs, analytical test results/reports, and stability data.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- 5+ years’ experience in pharma/biotech/medical device.
- Strong knowledge of GMP/GLP and regulatory expectations.
- Understanding of analytical testing and laboratory workflows.
- Familiarity with OOS investigations, deviations, and CAPA processes.
- Excellent organization and attention to detail; strong verbal/written communication.
- Strong interpersonal skills; ability to work on a team.
- 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 as needed.
Salary Range
- $109,000 USD – $121,000 USD