2nd Shift Batch Record Reviewer/Investigations Writer
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Accentuate Staffing is assisting a fast growing pharmaceutical company near the Charlotte, NC area who is looking for a Batch Record Reviewer/Investigations Writer to join their team. This is a direct hire opportunity working 2nd shift, 3pm-11:30pm Monday-Friday.
Responsibilities:
- Batch Record Reviewer will review BPR’s and conduct investigations for deviations and non conformances
- BPR Reviewer will conduct root cause analysis and write CAPAS
- BPR Reviewer will oversee batch record generation, CAPAs, deviations, etc.
- Reviewer will assist in evaluating deviation metrics to assist in process improvement plans
Requirements:
- Candidates must have 2 years experience with batch record review
- Candidates must have 2-3 years experience conducting investigations on the manufacturing and packaging floor
- Candidates must have hands on experience in pharmaceutical manufacturing and packaging processes reading/using BPR’s
- Bachelors degree in related field is preferred; Equivalent work experience or specific training required
- Candidates must have a strong knowledge of cGMPs, FDA regulations, Quality regulations
