Role:Batch Record Review / Manufacturing Documentation Specialist QA or Operations
Location: RTP, NC
Assignment Length: Minimum 6 months, with potential for extension
Rate: $40-45/Hr on w2.
Position Overview
Support pharmaceutical batch documentation completion through desk-based reviews, production-floor documentation checks, logbook reviews, and verification of scanned batch records and Component History Files.
Key Responsibilities
- *Batch Record Review:* Review executed batch records for completeness, signatures, calculations, attachments, and compliance with approved instructions.
- *Floor and Desk Coverage:* Perform documentation reviews at the desk and, when required, alongside ongoing manufacturing activities.
- *Logbook Review:* Identify missing entries, inconsistencies, and documentation discrepancies requiring clarification or correction.
- *Scan Verification:* Compare scanned batch records and Component History Files against source documents to verify completeness, legibility, page sequence, and correct identification.
- *Discrepancy Resolution:* Coordinate corrections, obtain missing documentation, and arrange rescanning when necessary.
- *Completion Tracking:* Track outstanding review comments and missing documentation required to complete batch record packages.
Required Background
- Pharmaceutical experience in QA batch record review, Manufacturing Operations documentation review, or manufacturing documentation support.
- Strong attention to detail and experience resolving documentation discrepancies.
- Knowledge of GMP/cGMP documentation requirements and controlled record practices.
- Experience reviewing scanned controlled records or working with electronic document repositories.
- Strong organizational and communication skills.
Salary
The hourly rate for this position is $40 $45/hr on W2, depending on experience and qualifications.
Benefits
Eligible employees may have access to benefits offered by Novozen Healthcare LLC in accordance with the applicable benefit plans and eligibility requirements.
Equal Employment Opportunity
Novozen Healthcare LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
Background Check
Background checks may be conducted in accordance with applicable law.