What are the responsibilities and job description for the Supervisor, Quality Assurance position at Amneal?
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.
Qualifications:
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.