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 year. 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.
About UsAmneal 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 [email protected]. Requests will be handled confidentially and in accordance with applicable laws.
Skills Required
- Bachelors Degree (BA/BS)
- 5 years or more in Quality or Document Control Experience
- cGMP knowledge
- Microsoft Office proficiency (MS Word, Excel, Access, PowerPoint)
Amneal Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Amneal Pharmaceuticals and has not been reviewed or approved by Amneal Pharmaceuticals.
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Healthcare Strength — Medical coverage is presented as comprehensive with day-one eligibility for many U.S. roles, supported by wellness resources and transparency around plan information.
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Affordable Benefits — Employer contributions toward health coverage are described as generous, including periods where cost increases were absorbed and future employee contributions kept below broader trends.
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Retirement Support — A 401(k) plan with a company match and strong participation is positioned as a core element of the Total Rewards package.
Amneal Pharmaceuticals Insights
What We Do
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
