Job Description

Document Control Manager oversees the organizational management of electronic and/or paper based system including but not limited to: Batch Record Issuance, Maintenance and Retention, including Protocols, reports, log books and other GMP documents . The Manager will lead the Document Control activities in regulatory inspections by reviewing documents for accuracy and compliance.

Schedule:

1st Shift 8:00am - 4:30pm Monday to Friday

Essential Functions:

• Manage document control processes thru electronic systems and/ or paper base systems.
• Maintaining lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department.
• Oversee distribution of all Controlled Documents, printing of SOPs, Methods, Specifications, Issuing Logbooks, and coordinate Biennial SOP review.
• 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, logbooks, laboratory notebooks, 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.
• Solve issues concerning documentation and/or change controls as required.

Additional Responsibilities:

• Manage daily performance of staff. Ensures projects, goals and deadlines are being met. Adhere to all budget requirements. Maintain high-level of confidentiality, in regards to Company and employee information. Additional responsibilities as assigned.

Education:

• Bachelors Degree (BA/BS) - Required

Experience:

• 5 years or more in Quality or Document Control Experience

Specialized Knowledge:

• cGMP, Microsoft Office (MS Word, Excel, Access, PowerPoint)

The base salary for this position ranges from $120,000 to $135,000 per hour. Amneal ranges reflect the Company’s good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.