QA Manufacturing Operations Specialist
Randstad USA · Plainville, MA · 4 days ago
On-siteEngineering$28–$30/hrContract
Job Summary
Responsibilities
- Perform real-time, on-the-floor Quality Assurance oversight of GMP manufacturing operations.
- Review executed batch records and GMP documentation for accuracy, completeness, and strict regulatory compliance.
- Support site investigations, deviations, CAPAs, and change controls in partnership with senior QA staff.
- Escalate quality events, compliance risks, and atypical observations to management in a timely manner.
- Collaborate closely with Manufacturing, QC, and support functions to ensure absolute adherence to site SOPs and FDA/EU guidelines.
Qualifications
- Required: Bachelor's degree in Life Sciences, Engineering, Microbiology, or a related field (equivalent training/experience considered).
- Minimum 1+ years of GMP industry-related experience.
- Working knowledge of FDA, EMA, and applicable GMP regulations and quality systems.
- Ability to gown fully and work comfortably within classified cleanroom manufacturing areas.
- Full availability for a Day Shift Flex 12 rotating schedule (6:45 AM-7:15 PM; Week 1: M/T/F/Sa; Week 2: Su/W/Th).
Preferred
- Proficiency with electronic quality systems (eQMS) and advanced documentation review.
Skills
- Microbiology
- Good Laboratory Practices (GLP)
- Good Manufacturing Practices (GMP)
- Corrective and Preventive Actions (CAPA)
Benefits
- Medical
- Prescription
- Dental
- Vision
- AD&D
- Life Insurance
- Short-term disability
- 401K plan