Document Control Assistant

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

Benefits offered by this job

Bonus opportunity

401(k) matching

Health benefits

Job summary

Amneal is seeking a Document Control Specialist to support documentation compliance in a pharmaceutical production facility. You will manage electronic and paper documents, ensure accuracy, and collaborate with QA, QC and Production to maintain integrity of documents.

The role focuses on maintaining control systems, archiving critical records, and distributing controlled documents across departments. Shift is 1st, Monday to Friday, 8:30am–5:00pm.

Qualifications

• High School or GED is required.
• Associate Degree is preferred.
• Less than one year of manufacturing experience.

Responsibilities

• Manage document control processes through electronic and/or paper systems; distribute approved documents.
• Track receipt of documents and notebooks and maintain related postings and databases.
• Perform data entry and manage documents in Document Compliance and Process Compliance systems; maintain print/soft copies.
• Collaborate with QA, Production and other teams to keep Document Control Systems current.
• Store, archive and retrieve certificates, specs, methods, protocols and reports.
• Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols; ensure online documents are up to date.

Skills

cGMP

Education

High School or GED

Associate Degree

Tools

MS Word

Excel

Access

Job description

Description:

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.

1st shift schedule - Monday to Friday - 8:30am -5:00pm

Essential Functions:

• 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.
• Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks. 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

Additional Responsibilities:

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

Education:

• High School or GED - Required
• Associate Degree - Preferred

Experience:

• less than one year in manufacturing

Specialized Knowledge:

• cGMP, Computer Skills (MS Word, Excel, Access)

The hourly rate for this position ranges from $20.00 to $25.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.