Executive, Quality Control
About this role
The position is responsible for in-process and final product quality analyses and inspection in compliance with approved standards and regulatory requirements. The role involves interpreting and evaluating analytical results for accuracy and precision against established specifications. The role uses measuring devices, testing equipment, predefined methods, operations, setups, and specifications to support acceptance or rejection of materials and products. The position identifies ongoing quality issues, prevents potential production problems, and recommends improvements. The role audits, monitors, and determines the quality of manufacturing processes and outputs, performs random testing of finished goods, and reports manufacturing process deviations and product defects, ensuring data integrity, GMP compliance, and regulatory adherence.
Essential Functions:
- Perform in-process and final product quality analyses and inspection
- Execute Finished Product (FP) Testing and IP/FP Analytical Testing
- Interpret analytical results for accuracy, precision, and compliance
- Operate measuring devices, laboratory instruments, and testing equipment
- Apply approved analytical methods, operations, and specifications
- Support acceptance or rejection decisions for materials and products
- Identify ongoing quality issues and prevent production risks
- Audit and monitor manufacturing processes and quality outputs
- Conduct random sampling and testing of finished goods
- Review and maintain GMP documentation and analytical records
- Report manufacturing process deviations and product defects
Additional Responsibilities:
- Participate in method validation, verification, and transfer activities as required.
- Assist in updating and reviewing SOPs, specifications, and analytical procedures.
- Contribute to continuous improvement initiatives in the QC department.
- Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor.
- Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.
Company at a glance
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.
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