Supervisor, Quality Assurance (Manufacturing)
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 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.
