Document Control Assistant - 2nd Shift
Amneal Pharmaceuticals · Piscataway, NJ · Yesterday
Accounting$20–$25/hrFull-time
Essential Functions
- Manage document control processes thru electronic systems and/ or paper base systems.
- Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.
- Maintaining lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department and training records.
- Perform data entry and management in systems (Document Compliance and Process Compliance) and maintain the print/soft copies for all documents.
- Collaborate with teams to complete, maintain an up-to-date Document Control Systems.
- Store, archive, and retrieve the version documents such as certificate of analysis of materials and products, specifications, methods, protocols, and report files.
- Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols, and other controlled documents.
- Track document approvals and any related activities and ensure on-line documents are updated and accurate.
- Work with other departments to clarify and correct documentation to ensure compliance.
- Organize and maintain the work area and keep up-to-date files
Additional Responsibilities
- Prepare documentation for third party inspection/audits.
- Auxiliary with validation and regulatory department for documentation and for their various requirements.
Qualifications
- Education: High School or GED - Required Associate Degree - Preferred
- Experience: 1 year of experience in Manufacturing or Document Control
- Specialized Knowledge: cGMP, Computer Skills (MS Word, Excel, Access)