Supervisor, Quality Assurance

Amneal

17h•Onsite

About The Position

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. This role is responsible for monitoring all stages of QA in-process/packaging operations to ensure strict compliance with cGMP/SOPs, assisting management with the development of new and revised SOPs, executing validation & qualification studies, performing investigations, and handling Change Controls, Deviations, Corrective Actions and Preventative Actions (CAPA) through effective quality management tools. The position also involves handling customer complaints, auditing batch records, and conducting internal audits.

Requirements

Knowledge of cGMPs.

Nice To Haves

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

Responsibilities

Schedules and coordinates 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.
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.
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.