QA Associate
About The Position
The QA Associate supports production-related quality activities to ensure processes, data, and documentation meet GMP and regulatory expectations. This role works closely with Microbiology, Manufacturing, and other Quality functions to help maintain a state of control across facilities and systems. This position is well-suited for someone with a microbiology background who is detail-oriented, thoughtful, and comfortable working within structured quality systems. Success comes from steady judgment, clear communication, and the confidence to ask questions or raise concerns when something does not look right.
Requirements
- Bachelor’s degree in Microbiology, Biology, or a related scientific discipline
- Experience in a GMP-regulated pharmaceutical, biotechnology, or similar environment
- Working knowledge of microbiology concepts such as environmental monitoring, contamination control, and aseptic practices
- Strong attention to detail and disciplined documentation habits
- Ability to follow established procedures and quality systems
- Clear written and verbal communication skills
Nice To Haves
- Prior experience in Quality Assurance or QC
- Familiarity with cleanroom operations and environmental monitoring programs
- Experience supporting audits or regulatory inspections
Responsibilities
- Provide Quality Assurance support and oversight for microbiology-related activities, including environmental monitoring and utility monitoring
- Review microbiology data, records, and reports for accuracy, completeness, and GMP compliance
- Support investigations related to microbial excursions, deviations, and OOS/OOT results
- Assist with CAPAs, change controls, and risk assessments that impact microbiology systems
- Ensure documentation is completed clearly, accurately, and in accordance with approved procedures
- Participate in internal audits, inspections, and readiness activities as needed
- Collaborate with Microbiology, Manufacturing, Validation, and broader Quality teams
- Escalate quality concerns promptly and appropriately through established channels
Benefits
- A stable, quality-focused work environment
- Clear expectations and structured onboarding
- Collaboration with experienced Quality professionals
- The opportunity to directly support product quality and compliance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
11-50 employees
