Description:
The Batch Record Reviewer Group Lead is responsible for leading and overseeing batch record review activities across manufacturing, packaging, and related operations in a pharmaceutical manufacturing environment. This role ensures timely, accurate, and compliant review of GMP documentation in accordance with regulatory requirements, internal procedures, and quality standards.
Essential Functions:
- Lead and perform detailed review of executed batch records (manufacturing, packaging, labeling, and R&D as applicable) for accuracy, completeness, and GMP compliance.
- Review work output for quality, consistency, and adherence to procedures.
- Serve as an escalation point for complex documentation issues or cross‑departmental concerns.
- Review and update manufacturing execution systems and/or ERP systems (e.g., JDE or equivalent) to ensure accurate batch status and documentation records.
- Coordinate issuance, control, and reconciliation of batch records, logbooks, labels, and controlled documents.
- Communicate documentation findings, trends, and improvement opportunities to supervisors and management.
- Collaborate with Manufacturing, Packaging, Quality Assurance, Production Planning, and Supply Chain to support work order execution and documentation readiness.
- Identify recurring documentation errors and support corrective and preventive actions (CAPAs).
- Participate in process improvement initiatives to enhance documentation accuracy, efficiency, and compliance.
Additional Responsibilities:
- Perform other duties as assigned to support quality and operational excellence.
Education:
- High School or GED - Required
Experience:
- 2 years or more in Manufacturing or Packaging
Specialized Knowledge:
- Strong knowledge of cGMP regulations and pharmaceutical documentation practices
- Excellent attention to detail and ability to identify documentation errors and trends
- Effective leadership, coaching, and communication skills
- Ability to manage multiple priorities and meet timelines in a fast‑paced environment
- Proficiency with ERP/MES systems (e.g., JDE or equivalent) and electronic documentation systems
- Strong organizational and problem‑solving skills
- Ability to work cross‑functionally and communicate clearly at all levels of the organization
The hourly rate for this position ranges from $27.00 to $35.00 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.
About Us
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 [email protected]. Requests will be handled confidentially and in accordance with applicable laws.
Skills Required
- High school diploma or GED
- At least 2 years of experience in manufacturing or packaging
- Strong knowledge of cGMP regulations and pharmaceutical documentation practices
- Excellent attention to detail and ability to identify documentation errors and trends
- Effective leadership, coaching, and communication skills
- Ability to manage multiple priorities and meet timelines in a fast-paced environment
- Proficiency with ERP/MES systems, such as JDE, and electronic documentation systems
- Strong organizational and problem-solving skills
- Ability to work cross-functionally and communicate clearly at all organizational levels
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.
