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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Amneal Pharmaceuticals by 2x
