Job Description
We are seeking a detail-oriented Documentation Specialist to support operations within a pharmaceutical manufacturing environment. This individual will play a key role in ensuring accuracy, compliance, and audit readiness across batch documentation and records.
What You’ll Do:
- Review pilot plant records (MWIs, FRs, cleaning documentation, etc.) for completeness and adherence to GDP standards
- Route documentation through proper workflows for closure
- Maintain and update batch tracking spreadsheets
- Support batch review as a secondary signature when needed
- Assist with material receipt and removal activities tied to batch completion
- Update SOPs and documentation as required
- File and organize records in accordance with retention policies
- Help maintain audit readiness across documentation and processes
Required Qualifications: