Officer, Quality Control Testing
About this role
Officer – Quality Control is responsible for executing and supporting routine QC laboratory activities, including analysis, documentation, and compliance with cGMP and GLP requirements. The role involves handling raw material, in-process, and finished product testing, supporting stability studies, maintaining instrument compliance, and assisting in deviation/OOS investigations. The position also supports data integrity, SOP adherence, and continuous improvement initiatives within the QC function.
Essential Functions – Officer, Quality Control
- Execute routine preventive maintenance, calibration, and verification activities of QC instruments as per approved SOPs.
• Perform analysis and support timely release of raw materials, intermediates, and packing materials as per approved specifications.
• Ensure day-to-day compliance with GLP, safety practices, and laboratory housekeeping requirements.
• Execute stability sample charging, withdrawal, testing, and documentation as per approved stability protocols.
• Support investigation of deviations, OOS, OOAL, and laboratory incidents; assist in implementation of CAPA.
• Prepare, revise, and follow QC-related SOPs, test methods, and specifications; ensure compliance in routine work.
• Perform audit trail checks and ensure adherence to data integrity requirements for computerized systems.
• Enter, verify, and maintain accurate analytical data and sample status in LIMS.
• Participate in training programs and support knowledge sharing within the QC team.
• Maintain analytical columns, reference standards, and laboratory consumables as per SOPs.
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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