Quality Control Manager

The Quality Control Manager establishes quality control guidelines and testing procedures. Ensures that raw material and finished product quality and reliability are in compliance with engineering and product specifications. Reviews quality control practices and procedures to ensure that quality standards are upheld.

What You Will Do:

• Responsible for overall management strategy for QC staff.
• Define priorities for the QC Analytical department. Ensure alignment of QC priorities with the site priorities/strategy, also ensuring strategy deployment.
• Leader in the Audit Room for ISO Audits, FDA Audits, Supplier Audits, and other applicable regulatory or non-regulatory body audits.
• Inspect, test, or measure raw materials used in production and finished goods being produced,
• Approved or reject materials according to standards established by Quality.
• Ensures any rejected products or materials are segregated per procedure.
• Collect, organize and report on KPI metrics and identify trends that require attention.
• Executes/Reviews validation protocols and procedures for new equipment.
• Manage and work with team to resolve non-conformances and other identified issues.
• Identify and manage business risks, opportunities in the QC Lab.
• Working knowledge of USP/EP compendial testing/requirements.

• Bachelors degree in science such as Chemistry, Microbiology, or Biochemistry, Chemical Engineering. or related scientific degree.
• 5 years' GMP experience working in a pharmaceutical environment, with Test Method and Instrumentation Validation in a QC Laboratory.
• Demonstrated experience commissioning a new QC laboratory.
• Experience with ETQ, Trackwise, Veeva, SAP, Open Lab or ChemStation.
• Quality System oversight, metrics and improvements including vendor monitoring, change controls, CAPA, escalation and risk management.
• Instrument qualifications IOQ, Validations, Calibration and operations.
• Experienced in change management, root cause analysis, risk assessment, OOS/OOT investigations.