Senior Quality Assurance Associate
About The Position
The purpose of this position is to perform tasks pertaining to assurance compliance with quality requirements, including reviewing and approving validation reports, conducting internal and external audits, and review of production batch records and associated documentation required to release a production lot. This position will provide quality oversight for second shift GMP manufacturing so must be able to work independently, manage time appropriately, and be able to make decisions regarding product quality. This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00 am – 8:00 am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.
Requirements
- High school diploma is required. Bachelor's degree is strongly preferred in a Life Sciences discipline or equivalent
- Minimum five (5) years of Quality experience, preferably batch review experience
- Must be able to effectively communicate within the department and cross-functionally with other divisions
- High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
- Superior attention to detail, organizational skills, and the ability to multi-task in a time line driven environment
- Experience working in the life science and/or pharmaceutical manufacturing industry
- Proven problem-solving skills
- Excellent oral and written communication skills, and listening skills
- Working knowledge of cGMP regulations, 21 CFR 820, ISO 13485, and good documentation practices
Responsibilities
- Review production batch record and associated documentation for lot disposition
- Investigate discrepancies and ensure all issues are resolved
- Prepare Certificate of Compliance (COC) or Certificate of Analysis (COA), as required
- Perform line clearance functions for cGMP processes
- Support manufacturing operations and staff to address product quality and compliance issues, as they arise
- Lead and/or assist investigations into quality issues such as complaints and Corrective and Preventive Actions (CAPAs)
- Perform visual inspection of finished product
Benefits
- Medical, Dental, and Vision Insurance
- Company-Paid Life Insurance (1x Annual Salary)
- Voluntary Life Insurance Options
- Short-Term and Long-Term Disability Insurance
- Flexible Spending Account (FSA) & Health Savings Account (HSA)
- 401(k) Retirement Plan with Company Matching
- 10 Days of Vacation
- 10 Paid Holidays Annually
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
11-50 employees
