What are the responsibilities and job description for the Documentation Specialist position at Katalyst CRO?
Roles & Responsibilities
- Documentation Management.
- Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO 13485 guidelines.
- Review production schedules with various departments to ensure alignment and efficiency.
- Manage the lifecycle of production documents, including creation, review, approval, and archiving.
- Manage the printing, distribution, and tracking of all production-related documentation.
- Batch Production Records (BPRs), Bills of Materials (BOMs), Protocols, and Labels for production, ensuring accuracy, traceability and compliance.
- Utilize systems such as SAP and other relevant software for documentation and data management.
- Cross-functional Collaboration on documentation improvement projects to maintain integrity and compliance.
- Liaise with various teams including Quality, Regulatory Affairs, and Supply Chain to ensure seamless information flow.
- High school diploma or equivalent experience required.
- 3-5 years in a GMP manufacturing environment
- Experience in the pharmaceutical or medical device industry
- Knowledge, Skills, Abilities
- Strong knowledge of cGMP regulations and ISO 13485 standards
- Proficiency in Microsoft Office suite
- Excellent organizational and communication skills
- High school diploma or equivalent experience required.
- 3-5 years in a GMP manufacturing environment.
- Experience in the pharmaceutical or medical device industry.
- Strong knowledge of cGMP regulations and ISO 13485 standards.
- Proficiency in Microsoft Office suite.