Position Summary
The Manufacturing Documentation Associate supports manufacturing compliance and batch release activities through document review, ERP transactions, data management, and production documentation. This role ensures accuracy, audit readiness, and compliance with cGMP, FDA, and company quality standards.
Key ResponsibilitiesDocumentation & Compliance
- Review BMRs, logbooks, and GMP documents for accuracy and compliance.
- Support timely batch release through documentation review and submission.
- Compile validation and qualification documentation for manufacturing equipment.
- Issue and maintain manufacturing documents, forms, and logbooks.
Manufacturing Support
- Create BOPs in Progen and complete ERP manufacturing transactions.
- Maintain batch execution records, yield data, and production trackers.
- Coordinate documentation activities for visual inspection and packaging operations.
- Support training coordination and audit readiness activities, including GEMBA walks.
Quality & Environmental Compliance
- Ensure compliance with cGMP, GDP, safety, and quality requirements.
- Support hazardous waste management in accordance with environmental regulations.
- Perform additional duties as assigned.
QualificationsRequired
- Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
- 2-4 years of experience in pharmaceutical manufacturing, documentation, or GMP-regulated environments.
- Experience reviewing batch records and GMP documentation.
- Strong attention to detail and organizational skills.
Preferred
- Experience in pharmaceutical manufacturing or GMP-regulated environments.
- Familiarity with ERP systems and manufacturing documentation.
- Knowledge of cGMP, GDP, and FDA requirements.
Key Competencies
- Documentation Management
- Batch Record Review
- cGMP Compliance
- Data Integrity
- ERP Systems
- Audit Readiness
- Attention to Detail
- Organization & Planning
- Team Collaboration
What Success Looks Like
- Batch documentation is reviewed accurately and submitted on time.
- Manufacturing records and ERP transactions are maintained with accuracy and compliance.
- Audit readiness and quality standards are consistently maintained.
- Documentation supports efficient manufacturing operations and timely batch release.
