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QA Batch Record Reviewer
On-site · Cincinnati, Ohio, United States
Job Summary
Quality-on-the-Floor Specialist role at Thermo Fisher Scientific OS D site in Cincinnati focuses on QA oversight of manufacturing processes, deviation reporting, and rapid investigations to ensure GMP compliance. Responsibilities include acting as QA point of contact for RAPID events, authoring deviation reports, coordinating with QA, Operations, Engineering, and client QA, performing in-process QA checks prior to batch initiation, supporting Change Control activities, conducting annual Fit & Finish audits to FDA requirements, and maintaining safe working conditions. The position requires 12-hour night shifts (EOWN: Thursday–Saturday 6:00 PM–6:30 AM) with a training period of 1–3 months (Mon-Fri, 8 AM–5 PM). Requires a Bachelor’s degree in a Life Sciences/Engineering field (or equivalent), 3–5 years in GMP manufacturing quality/QA, and familiarity with SAP or ERP systems. Must be able to pass background and drug screening and be legally authorized to work in the United States without sponsorship. Relocation assistance is not offered.
Required Qualifications
- Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or a related field (or equivalent experience)
- 3–5 years of experience in pharmaceutical manufacturing, biologics, or regulated manufacturing environments
- Experience in quality assurance or operations within GMP environment (pharmaceutical, biotech, or medical device preferred)
- Experience with batch record review preferred
- Familiarity with SAP or other ERP systems preferred
- Strong knowledge of cGMP, GDP, and FDA/EMA regulatory expectations
- Understanding of pharmaceutical manufacturing processes and cleanroom operations
- Familiarity with batch record documentation and data integrity principles
- Strong attention to detail and documentation accuracy
- Effective communication and on-the-floor coaching ability
- Ability to identify compliance gaps and drive immediate corrective actions
- Organizational and time-management skills
- Strong verbal and written communication skills
- Strong interpersonal skills with the ability to collaborate across functions and levels
- Ability to work independently to consistently meet daily and weekly expectations
Additional Requirements
- Must be legally authorized to work in the United States without sponsorship, now or in the future.
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