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Documentation Specialist
Documentation SpecialistKatalyst HealthCares & Life Sciences • Ridgefield,, NJ
Documentation Specialist

Documentation Specialist

Katalyst HealthCares & Life Sciences • Ridgefield,, NJ
30+ days ago
Job type
  • Full-time
Job description

Roles & Responsibilities :
  • Documentation Management.
  • Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO 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.
Education & Experience:
  • High school diploma or equivalent experience required.
  • - years in a GMP manufacturing environment
  • Experience in the pharmaceutical or medical device industry
  • Knowledge, Skills, Abilities
  • Strong knowledge of cGMP regulations and ISO standards
  • Proficiency in Microsoft Office suite
  • Excellent organizational and communication skills
  • High school diploma or equivalent experience required.
  • - years in a GMP manufacturing environment.
  • Experience in the pharmaceutical or medical device industry.
  • Strong knowledge of cGMP regulations and ISO standards.
  • Proficiency in Microsoft Office suite.

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Documentation Specialist • Ridgefield,, NJ

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