Document Control & Compliance Associate

RXinsider LTD.; Piscataway Township (NJ); Hybrid; USD 28,000 - 34,000; Full time

Benefits offered by this job

Bonus opportunities

Long-term incentive awards

401(k) matching

Comprehensive benefits

Job summary

Amneal is hiring a Document Control Assistant to administer processes supporting documentation compliance in a pharmaceutical production facility in New Jersey. You will work with QA, QC and Production to ensure accuracy, quality and integrity of documentation.

Responsibilities include managing document control systems, data entry, archiving, distributing controlled documents, and preparing records for audits.

Qualifications

• High School or GED required.
• Associate Degree preferred.
• 1 year of experience in Manufacturing or Document Control.

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.
• Maintain lists and postings for electronic and hard copy; maintain databases in Document Control Department and training records.
• Perform data entry and management in systems and maintain print/soft copies for all documents.
• Collaborate with teams to complete, maintain up-to-date Document Control Systems.
• Store, archive and retrieve version documents such as COAs, specs, methods, protocols, and reports.
• Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols; other controlled documents.
• Track document approvals and online updates; ensure accuracy.
• Prepare documentation for third party inspection/audits.
• Assist validation and regulatory department for documentation.

Skills

cGMP

Documentation processes

Education

High School or GED

Associate Degree

Tools

MS Word

Excel

Access

Job description

Amneal is hiring a Document Control Assistant to administer processes supporting documentation compliance in a pharmaceutical production facility in New Jersey. You will work with QA, QC and Production to ensure accuracy, quality and integrity of documentation.

Responsibilities include managing document control systems, data entry, archiving, distributing controlled documents, and preparing records for audits.