QA Specialist 2, Floor Support
On-siteWinston-Salem, North Carolina, United States
Job Summary
Provide real-time QA support for low-complexity manufacturing and facility activities in classified environments while maintaining continuous on-floor presence. Perform basic in-process batch record reviews, review routine documentation such as logbooks and equipment use records, and conduct line clearance activities using established procedures. Identify and document quality observations, support deviation documentation and investigations, and participate in audits and cross-functional quality initiatives. Follow all gowning, safety, and cleanroom behavior requirements. This onsite role requires full-time presence Sunday through Thursday with over time and flexibility needed based on business needs.
Required Qualifications
- 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
- 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
- Full-time onsite work in a GMP manufacturing environment
- Not eligible for remote or hybrid work
- Full gowning and extended time in cleanroom and classified areas
- Ability to stand for extended periods and perform physical tasks as required
- Eligible to work in the United States without the need for work visa or residency sponsorship
Desired Qualifications
- Exposure to aseptic manufacturing preferred
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