Description:
The Supervisor, Quality Assurance, schedules and coordinates daily priorities for incoming raw materials and labeling components, in-process testing, finished product sampling, in-process labeling and packaging operations, sampling and inspection activities on all work shifts.
Essential Functions:
- Responsible for scheduling and coordinating daily priorities for incoming raw material, in-process material, finished product and in-process packaging/labeling operations sampling and inspection activities.
- Trains, supervises and evaluates the performance of QA inspectors, QA Specialist and QA Auditors to assure compliance with Standard Operating Procedures (SOPs)/cGMP.
- Responsible for final product: Monitors all stages of QA in-process/packaging operations to ensure strict compliance with cGMP/SOPs.
- Assists management with the development of new and revised SOPs, executes validation & qualification studies, performs investigations and other assignments as required.
- Handles Change Controls, Deviations, Corrective Actions and Preventative Actions (CAPA) through effective quality management tools.
- Handles customer complaints to include retrieval of samples, performing applicable tests, preparation of reports and submission before due date.
- Monitors and ensures that batch records are audited per manufacturing/packaging/shipping requirements, when required.
- Conducts internal audits for compliance with SOP, cGMP & FDA requirements.
Additional Responsibilities:
- Initiates, investigates and completes CAPA for all QA unplanned deviations under the guidance of QA Manager.
- Writes, reviews and revises SOPs as directed by QA Manager/Director.
- Plans, monitors and supervises cross training of all QA Inspectors.
- Monitors absences and prepares Kronos, HR requestions/data change forms for all shift personnel, whenever required.
- Reviews performance of all QA Inspectors in the shift as and when directed by HR.
Education & Experience
- Bachelor’s Degree (BA/BS): Minimum 1 year of pharmaceutical/manufacturing experience, including 1+ year in a supervisory or lead role
- Associate Degree (AA/AS): Minimum 5 years of pharmaceutical/manufacturing experience, including 2+ years in a supervisory or lead role
- High School Diploma or GED: Minimum 3 years of pharmaceutical/manufacturing experience, including 5+ years in a supervisory or lead role
Specialized Knowledge:
- Knowledge of cGMPs.
Skills Required
- Bachelor's degree (BA/BS) with minimum 1 year pharmaceutical/manufacturing experience, including 1+ year in a supervisory or lead role
- Associate degree (AA/AS) with minimum 5 years pharmaceutical/manufacturing experience, including 2+ years in a supervisory or lead role
- High School Diploma or GED with minimum 3 years pharmaceutical/manufacturing experience, including 5+ years in a supervisory or lead role
- Knowledge of current Good Manufacturing Practices (cGMP)
- Experience training, supervising and evaluating QA inspectors, specialists and auditors
- Experience scheduling and coordinating sampling, inspection, in-process testing, and labeling/packaging QA activities
- Experience writing, reviewing and revising Standard Operating Procedures (SOPs) and executing validation and qualification studies
- Experience handling Change Controls, Deviations, Corrective and Preventative Actions (CAPA)
- Experience conducting internal audits for SOP, cGMP and FDA compliance
- Experience investigating and handling customer complaints, including sample retrieval, testing and report preparation
- Experience using Kronos and preparing HR requisitions/data change forms
- Ability to monitor batch record audits per manufacturing/packaging/shipping requirements
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.
