Documentation Specialist

Job Title: Documentation Specialist
Location: Ridgefield, NJ
Duration:12 Months

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.
Keys to Success:
Your proven attention to detail and ability to collaborate across functions will be vital. Successfully implementing compliance standards and supporting our ambitious manufacturing goals will drive your success.
Education
• High school diploma or equivalent experience required.
Experience
• 3-5 years in a GMP manufacturing environment is preferred
• 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
Physical Requirements / Work Environment
Work in a dynamic manufacturing environment requiring the ability to handle physical tasks such as document management and coordination with multiple departments.