Description:
Review batch records for timeliness and accuracy.
Schedule:
1st Shift 7am - 3:30pm Monday to Friday
Essential Functions:
- Perform final review of manufacturing documentation and provide support in areas of compliance for batch releases.
- Provide lot status updates as requested.
- Perform and/or support final release of batch records.
- Document and submit reports and documentation errors to management, for trend and training analysis.
- Provide support to the Compliance and Investigation groups, Quality Assurance- manufacturing floor groups during real time reviews, and also assist other departments with batch record retrieval and filing.
- Provide support during internal/external audits, as requested.
Additional Responsibilities:
- Perform additional duties as requested.
- Participate in and support continuous improvement activities, maintain a clean and organized work space area to ensure compliance.
Education:
- High School or GED General - Required
Experience:
- 2 years or more in Pharmaceutical, manufacturing, auditing or related experience
Skills:
- Ability to read, write and communicate in English at a level to facilitate the understanding of the terminology of the job - Advanced
- Ability to comprehend and follow written and verbal procedures or instructions Computer Knowledge (Excel and Power Point) - Advanced
- Ability to apply basic math and mechanical skills - Advanced
Specialized Knowledge:
- Competent knowledge of SOPs, cGMPs and competent mechanical aptitude
- Good problem solving skills
- Flexibility to rapidly adjust to changing job requirements
- Good communication skills
- Release of production rooms, along with in-process checks and review/audit of E-Log books
- Entry of engineering work orders, including coordination and tracking of preventive maintenance activities
- Performing operator level job responsibilities in production areas as part of cross-functional activities, if needed
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The hourly base salary for this position ranges from $17.50 to $23.50 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.
About UsAmneal 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.
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.
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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.
