Quality Control Supervisor

QC Supervisor

Leads quality control inspectors to inspect biological product at various stages of the production process while emphasizing quality.

Responsibilities

• Supervises and trains Quality Control Inspectors to ensure inspections at Biologics in accordance to Standard Operating Procedures, GMP and Regulatory Requirements.
• Provides technical direction to the QC Inspectors.
• Prioritizes the completion of quality inspection tasks to meet production deadlines
• Reviews and audits documentation to ensure accuracy.
• Audit cleanroom for correction of GMP and GDP
• Leads the Material Review Board for disposition of non-conforming in-process and finished goods.
• Interprets engineering drawings, schematic diagrams to complete inspections.
• Able to use a wide assortment of QC inspection instruments (rulers, calipers, gauges, and micrometers) to assure components and devices are manufactured and functioning according to specification and for the completion of equipment calibration.
• Assist with aseptic processing within the CEMA
• Gowning Training and Qualification
• Aseptic Processing Qualifications
• Prepares graphs and charts summarizing inspection data.

Qualifications

• Three to five years experience managing a QC function in the medical device industry.
• Associate or bachelor’s degree is desirable but not mandatory.