Document Control Assistant

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

Benefits offered by this job

Health benefits

401(k) matching

Bonus program

Job summary

Amneal is seeking a Document Control Specialist for its New Jersey pharmaceutical manufacturing facility. You will administer document control processes, ensure cGMP compliance, and collaborate with QA, QC and Production to maintain accuracy and integrity of documentation.

Responsibilities include electronic and paper document control, data entry, training record maintenance, preparation for audits, and archiving.

Qualifications

• High School or GED required.
• Associate degree preferred.
• Less than one year in manufacturing.

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 required for both electronic and hard copy; maintain specific databases in Document Control Department and training records.
• 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.

Skills

cGMP knowledge

MS Word

Excel

Access

Education

High School or GED

Associate Degree

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.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.