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 requistions/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:
Bachelors Degree (BA/BS) Preferred degree in Chemistry, Biology or other related technical field - Preferred
Associate Degree Pharmaceutical or related degree with 2 years Pharmaceutical/Manufacturing experience including 2 years supervising staff or working in a lead role. - Preferred
High School or GED General/HS Curriculum with 5 years pharmaceutical/Manufacturing Experience, including 3+ supervising staff or working in a lead role. - Required
Experience:
1 year or more in With a BA/BS -Pharmaceutical/Manufacturing experience including 1+ supervising staff or working in a lead role.
2 years or more in With an AA/AS Pharmaceutical or related degree with 5 years Pharmaceutical/Manufacturing experience including 2+ supervising staff or working in a lead role.
3 years or more in HS/GED with 3 years pharmaceutical/Manufacturing Experience, including 5+ supervising staff or working in a lead role.
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
Specialized Knowledge:
Knowledge of cGMPs.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
