Job Summary

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.

Qualifications

Education

• Associate Degree - Preferred

Work Experience

• Less than one year in manufacturing - Preferred

Skills and Abilities

• 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)

The starting hourly rate for this position ranges from $17.00 to $20.00. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.