Pharma Document Control Specialist — 2nd Shift

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 28,000 - 34,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Document Control Specialist for our New Jersey production facility on the 2nd shift (Mon-Fri 3:00pm-11:30pm). You will administer documentation controls to support compliance with cGMP and QA collaboration.

Responsibilities include managing document control processes, maintaining databases, and distributing approved docs; you will prepare PBRs and SOPs, archive records, and assist audits. Associates degree preferred; MS Word/Excel/Access skills helpful.

Qualifications

• High School or GED required.
• Associate degree preferred.
• Less than one year in manufacturing.
• Familiarity with cGMP and MS Office desktop tools.

Responsibilities

• Manage document control processes through electronic and paper systems.
• Distribute approved documentation to personnel and track receipt.
• Maintain databases in Document Control and training records.
• Perform data entry in Document Compliance and Process Compliance systems.
• Prepare and distribute PBRs, Packaging Batch Records, SOPs and methods.
• Prepare documentation for third party inspections/audits.
• Assist validation and regulatory for documentation requirements.

Skills

cGMP

Education

High School or GED

Associate degree

Tools

MS Word

Excel

Access

Job description

Amneal Pharmaceuticals LLC is seeking a Document Control Specialist for our New Jersey production facility on the 2nd shift (Mon-Fri 3:00pm-11:30pm). You will administer documentation controls to support compliance with cGMP and QA collaboration.

Responsibilities include managing document control processes, maintaining databases, and distributing approved docs; you will prepare PBRs and SOPs, archive records, and assist audits. Associates degree preferred; MS Word/Excel/Access skills helpful.