What are the responsibilities and job description for the Supervisor, Quality Assurance - 3rd Shift 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 requisitions/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:
- High School Diploma or GED – Required
- Bachelor’s Degree (BA/BS) in Chemistry, Biology, or a related technical field – Preferred
Experience:
- With a High School Diploma or GED: 5 years in a supervisory or lead role with 3 years of pharmaceutical or manufacturing experience.
- With an AA/AS: 2 years in a supervisory or lead role with 5 years of pharmaceutical or manufacturing experience.
- With a BA/BS or Higher: 1 year in a supervisory or lead role with 1 year of pharmaceutical or manufacturing experience.
Skills:
- To be a team leader and player who can successfully meet the organization's goals within a stipulated time frame. - Intermediate
- Must be able to multitask and adapt to a rapidly changing environment. - Intermediate
- Strong communication and writing skills. - Intermediate
- Must be able to problem solve and make decisions with limited supervision. - Intermediate
- Must be able to lead, coach and supervise the team with flexibility. - Intermediate
- Microsoft Office; able to learn in-house computer systems and software. - Intermediate
