Quality Control Manager
Ecolab
- King of Prussia, PA
- Permanent
- Full-time
- 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, training and troubleshooting experience with HPLC, GC, Alpine Jet Sieve, IR (infra red), KF (Karl Fisher), Moisture analyzer, ICP, Stability, UV/ Vis Spectrometer.
- Working knowledge of USP/EP compendial testing/requirements.
- Bachelor's degree in science such as Chemistry, Microbiology, or Biochemistry, Chemical Engineering. or related scientific degree.
- 5 years' GMP experience working in a pharmaceutical environment.
- Demonstrated experience commissioning a new QC laboratory, Method Validation, Instrument qualifications IOQ, PQ, Calibration and daily QC Lab operations.
- 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.