Document Control Specialist, Quality

Amneal Pharmaceuticals, Inc. Brookhaven , NY 11719

Posted 3 days ago

Description:

  • The document control specialist is responsible for implementing and managing 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. Also this position will interact with other operating and staff groups within the organization, including, but not limited to Engineering, R&D, Analytical R&D, Purchasing, Regulatory Affairs, Clinical Affairs, Sales/Marketing. Least

Essential Functions:

  • Manage document control processes thru electronic systems and/ or paper base systems.

  • 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.

  • Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.

  • Work with other departments to clarify and correct documentation to ensure compliance.

  • Organize and maintain the work area and keep up-to-date files

  • Maintain high-level of confidentiality, in regards to Company and employee information.

Additional Responsibilities:

  • For Quality:

  • Issue, receive, archive and track logbooks, batch records, etc.

  • 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:

  • 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)

Licenses:


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Document Control Specialist, Quality

Amneal Pharmaceuticals, Inc.