The document control specialist is responsible for administering the processes and practices which support documentation compliance. The Specialist will work in a pharmaceutical production facility and in close collaboration with Quality Assurance, Quality Control and Production with a key-focus on documentation accuracy, quality and integrity.
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.
Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks. 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.
Assist validation and regulatory department for documentation and for their various requirements.
Education:
High School or GED - Required
Associate Degree - Preferred
Experience:
less than one year in manufacturing
Skills:
2 years of QA Documentation - Intermediate
cGMP and computer skills (MS Word, Access and Excel) - Advanced
Multitasking and flexibility to accommodate changing priorities. - Advanced
Specialized Knowledge:
cGMP, Computer Skills (MS Word, Excel, Access)
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
