Document Control Assistant - 2nd Shift

Document Control Assistant

The Document Control Assistant 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.

Qualifications:

• High School or GED - Required
• Associate Degree - Preferred

• 1 year of experience in Manufacturing or Document Control

• cGMP, Computer Skills (MS Word, Excel, Access)

Required Skills:

• Change Control
• Data Entry
• Detail Oriented
• Document Management Systems
• Organizational Skills
• Writing

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at View email address on click.appcast.io. Requests will be handled confidentially and in accordance with applicable laws.