Document Control Assistant - 2nd Shift

Amneal • Piscataway, NJ

7d • $20 - $25 • Onsite

About The Position

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.

Requirements

• High School or GED - Required
• 1 year of experience in Manufacturing or Document Control
• cGMP
• Computer Skills (MS Word, Excel, Access)

Nice To Haves

• Associate Degree - Preferred

Responsibilities

• 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.
• Prepare documentation for third party inspection/audits.
• Assist validation and regulatory department for documentation and for their various requirements.

Benefits

• short-term incentive opportunity, such as a bonus or performance-based award
• long-term incentive award, such as restricted stock units
• comprehensive, flexible and competitive benefits program
• above-market, diverse and robust health and insurance benefits
• 401(k) matching contribution
• programs that help you enjoy your career alongside life’s many other commitments and opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED