Supervisor, Quality Assurance - 2nd Shift

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.
30+ days ago