What are the responsibilities and job description for the Documentation Specialist position at Jobs via Dice?
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We are looking for Documentation Specialist for our client in Ridgefield, NJ
Job Title: Documentation Specialist
Job Location: Ridgefield, NJ
Job Type: Contract
Job Description:
Pay Range: $25hr - $30hr
We are looking for Documentation Specialist for our client in Ridgefield, NJ
Job Title: Documentation Specialist
Job Location: Ridgefield, NJ
Job Type: Contract
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.
- Proven attention to detail.
- Ability to collaborate effectively across functions.
- Commitment to implementing compliance standards.
- 3 5 years in a GMP manufacturing environment preferred.
- Experience in the pharmaceutical or medical device industry.
- 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.
- Strong knowledge of cGMP regulations and ISO 13485 standards.
- Proficiency in Microsoft Office suite.
- Excellent organizational and communication skills.
- High school diploma or equivalent experience.
Salary : $25 - $30