What are the responsibilities and job description for the Documentation Specialist (GMP) position at The Fountain Group?
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 within 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
Salary : $25 - $30