Supervisor, Quality Assurance

About the role

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, and sampling and inspection activities on all work shifts.

Responsibilities

• Schedule and coordinate daily priorities for incoming raw material, in-process material, finished product, and in-process packaging/labeling operations sampling and inspection activities.
• Train, supervise, and evaluate the performance of QA inspectors, QA Specialists, and QA Auditors to ensure compliance with Standard Operating Procedures (SOPs) and cGMP.
• Monitor all stages of QA in-process and packaging operations to ensure strict compliance with cGMP and SOPs for final product release.
• Assist management with the development of new and revised SOPs, execute validation and qualification studies, and perform investigations as required.
• Handle Change Controls, Deviations, Corrective Actions, and Preventative Actions (CAPA) using effective quality management tools.
• Manage customer complaints, including retrieval of samples, performing applicable tests, preparing reports, and ensuring timely submission.
• Monitor and ensure batch records are audited per manufacturing, packaging, and shipping requirements.
• Conduct internal audits for compliance with SOPs, cGMP, and FDA requirements.
• Initiate, investigate, and complete CAPA for all QA unplanned deviations under the guidance of the QA Manager.
• Write, review, and revise SOPs as directed by the QA Manager or Director.
• Plan, monitor, and supervise cross-training of all QA Inspectors.
• Monitor absences and prepare Kronos, HR requisitions, and data change forms for all shift personnel as required.
• Review the performance of all QA Inspectors in the shift as directed by HR.

Qualifications

Education & Experience

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

Specialized Knowledge

• Knowledge of cGMPs.