Document Control Assistant

Amneal India • Piscataway, NJ

1d • $20 - $25 • Onsite

About The Position

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. The schedule for this position is 1st shift, Monday to Friday, from 8:30 am to 5:00 pm.

Requirements

• High School or GED - Required
• Less than one year in manufacturing
• cGMP
• Computer Skills (MS Word, Excel, Access)

Nice To Haves

• Associate Degree - Preferred

Responsibilities

• Manage document control processes through electronic systems and/or paper-based systems.
• Distribute approved documentation to appropriate personnel and track receipt of documentation and notebooks.
• Maintain lists and postings required for both electronic and hard copy.
• Maintain specific databases in the Document Control Department and training records.
• Perform data entry and management in systems (Document Compliance and Process Compliance).
• Maintain print/soft copies for all documents.
• Collaborate with teams to complete and maintain up-to-date Document Control Systems.
• Store, archive, and retrieve version documents such as certificates 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 departments with documentation and their various requirements.

Benefits

• Short-term incentive opportunity (bonus or performance-based award)
• Comprehensive, flexible, and competitive benefits program
• Above-market, diverse, and robust health and insurance benefits
• Significant 401(k) matching contribution
• Employee well-being programs

What This Job Offers

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