Documentation Specialist

Documentation Specialist | Ridgefield, NJ

• Pay: $25-30/hr.
• Shift: 2nd shift | Sun-Sat
• 12-month assignment with possibility for extension or conversion based on performance and budget.

• Review and verify Batch Production Records (BPRs) to ensure accuracy and compliance with internal specifications, cGMP regulations, and ISO 13485 standards.
• Manage the full lifecycle of production documents, including creation, revision, approval, issuance, distribution, and archival.
• Oversee printing, tracking, and control of production documentation such as BPRs, Bills of Materials (BOMs), Protocols, and Labels to maintain traceability and regulatory compliance.
• Review daily and weekly production schedules and collaborate with cross-functional teams to ensure alignment, efficiency, and timely execution.
• Maintain organized and compliant documentation systems using tools such as SAP and other relevant data management software.
• Partner with departments including Quality, Regulatory Affairs, Supply Chain, and Production to support documentation improvements and ensure seamless communication.
• Support ongoing compliance initiatives by identifying documentation gaps, implementing updates, and assisting with process optimization projects.
• Uphold strict adherence to cGMP and ISO 13485 standards while contributing to inspection readiness and continuous improvement efforts.

• High School Diploma required at a minimum
• 3+ years of experience within a cGMP regulated environment required
• Experience with in pharma/medical device industry is preferred
• Experience reviewing and verifying BPRs (batch production records) and/or BOMs (bills of materials)
  required
• Experience with management of the lifecycle of production documents highly preferred
• Experience with ISO 13485 regulations preferred
• Experience with SAP preferred