Documentation Specialist

7 days ago

Ridgefield, NJ, United States Cynet Systems Full time
Job Description:

Pay Range: $25hr - $30hr
  • The Documentation Specialist will manage and maintain manufacturing documentation to ensure compliance with internal specifications, cGMP regulations, and ISO 13485 guidelines.
  • This role involves reviewing and verifying production records, coordinating with cross-functional teams, and supporting continuous improvement initiatives to maintain data integrity and operational efficiency.
Requirement/Must Have:
  • Proven attention to detail.
  • bility to collaborate effectively across functions.
  • Commitment to implementing compliance standards.
Experience:
  • 3-5 years in a GMP manufacturing environment preferred.
  • Experience in the pharmaceutical or medical device industry.
Responsibilities:
  • Review and verify manufacturing Batch Production Records (BPRs) for 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 printing, distribution, and tracking of all production-related documentation such as BPRs, Bills of Materials (BOMs), Protocols, and Labels, ensuring accuracy, traceability, and compliance.
  • Utilize systems such as SAP and other relevant software for documentation and data management.
  • Collaborate cross-functionally on documentation improvement projects to maintain integrity and compliance.
  • Liaise with Quality, Regulatory Affairs, and Supply Chain teams to ensure seamless information flow.
Skills:
  • Strong knowledge of cGMP regulations and ISO 13485 standards.
  • Proficiency in Microsoft Office suite.
  • Excellent organizational and communication skills.
Qualification And Education:
  • High school diploma or equivalent experience.

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