Document Control Assistant

Amneal

1d • 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. This is a 1st shift schedule, Monday to Friday, 8:30 am - 5:00 pm.

Requirements

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

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 (bonus or performance-based award)
• Health and insurance benefits
• 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