QA Specialist 2, Floor Support
- Provide real-time QA support for low-complexity manufacturing and facility activities in classified environments.
- Maintain continuous on-floor presence to support compliance and production activities.
- Perform basic in-process batch record reviews to ensure accuracy and compliance.
- Review routine documentation such as logbooks, equipment use records, and cleaning logs and follow up on discrepancies.
- Conduct and verify routine line clearance activities using established procedures and checklists.
- Identify and document quality observations; escalate non-routine or higher risk issues as appropriate.
- Support deviation documentation, investigations, and remediation with guidance.
- Participate in audits, inspections, and cross-functional quality initiatives as assigned.
- Follow all gowning, safety, and cleanroom behavior requirements.
- Bachelor's degree in Biotechnology, Biology, Chemistry, or related field; or equivalent combination of education and experience.
- 2 years of QA experience in a GMP-regulated manufacturing, laboratory, or quality environment.
- Exposure to aseptic manufacturing preferred.
- Working knowledge of cGMP principles and quality systems.
- Ability to apply defined procedures and exercise judgement within established parameters.
- Strong attention to detail and documentation accuracy.
- Effective organizational, communication, and collaboration skills.
- Ability to perform physical tasks and work in gowning-required environments.
- This position requires full-time onsite work in a GMP manufacturing environment.
- Not eligible for remote or hybrid work.
- Requires full gowning and extended time in cleanroom and classified areas.
- Ability to stand for extended periods and perform physical tasks as required.
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