Associate II, Plant Quality Assurance
$90,000–$116,500 year
On-siteFramingham, Massachusetts, United States
Job Summary
Provide on-floor Quality Assurance support to ensure manufacturing and testing activities comply with cGMP requirements and approved procedures. Perform quality walkthroughs and inspections to identify compliance concerns, then review and close quality records including minor deviations. Analyze production batch records, logbooks, and laboratory documentation for accuracy, while assisting in authoring and revising standard operating procedures. Guide manufacturing and support personnel on quality system requirements and escalate compliance risks to management as appropriate. Support internal and external audits and regulatory inspections as required. Collaborate with cross-functional teams to maintain an inspection-ready environment and promote a quality-focused culture.
Required Qualifications
- BA or BS degree in a scientific discipline or related field, or equivalent combination of education and relevant experience
- 1-4 years of experience in the pharmaceutical, biotechnology, or related regulated industry
- High level of attention to detail
- Excellent time management
- Strong written and verbal communication skills
- Demonstrated ability to work collaboratively across multiple departments
- Experience providing quality support within a GMP manufacturing environment
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