Senior Associate, Plant Quality Assurance
$99,500–$128,500 year
On-siteFramingham, Massachusetts, United States
Job Summary
Provide on-floor Quality Assurance support during second shift operations to ensure manufacturing and testing activities comply with cGMP requirements and approved procedures. Perform quality walkthroughs and inspections to identify compliance concerns, while reviewing production batch records, logbooks, and laboratory documentation for accuracy. Support the timely closure of quality records, including deviations, CAPAs, and change controls, and participate in root cause investigations to develop corrective and preventative actions. Escalate quality issues and compliance risks to management as appropriate. This role includes a 5-day on-site expectation at the Framingham location. You will collaborate with cross-functional teams to promote quality objectives and support internal and external audits.
Required Qualifications
- BA or BS degree in a scientific discipline or related field, or equivalent combination of education and relevant experience
- 3–5+ years of experience in the pharmaceutical, biotechnology, or related regulated industry
- Minimum of 3 years of experience in Quality Assurance, Quality Control, Manufacturing, or a related GMP-regulated function
- Working knowledge of cGMP regulations, GDP requirements, and quality systems
- Ability to manage multiple priorities in a fast-paced manufacturing environment
- Strong written and verbal communication skills
- Experience reviewing GMP documentation and quality records
- Demonstrated ability to work collaboratively across multiple departments
- This position is based in our Framingham location and typically has a 5-day on-site expectation
Desired Qualifications
- Experience providing quality support within a GMP manufacturing environment preferred
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