Supervisor, Quality Assurance

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 requestions/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 & Experience

• Bachelor's Degree (BA/BS): Minimum 1 year of pharmaceutical/manufacturing experience, including 1+ year in a supervisory or lead role
• Associate Degree (AA/AS): Minimum 5 years of pharmaceutical/manufacturing experience, including 2+ years in a supervisory or lead role
• High School Diploma or GED: Minimum 3 years of pharmaceutical/manufacturing experience, including 5+ years in a supervisory or lead role

Specialized Knowledge:

• Knowledge of cGMPs.