Curium Pharma · 2 days ago

Senior Quality Control Testing Engineer

Maryland Heights, MO

Full-time

Onsite

Senior Level

5+ years exp

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Pharmaceutical

Hiring Manager

Michael Gruen

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Responsibilities

Perform Preventative Maintenance and Demand Maintenance on QC instruments and equipment

Author and execute analytical method, and equipment/instrument IQ/OQ/PQ protocols.

Coordinate with external contractors to facilitate instrument maintenance and repairs

Author Standard Operating Procedures for new instruments/software

While working in a cGMP environment, he/she must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, NRC, Health Canada, OSHA, etc.)

Author Change Controls, Protocols, Corrective and Preventive Action items and Periodic Reviews.

Assure compliance with department training and qualification.

Work safely with radioactivity and ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.

Authors Change Controls in Quality Management systems.

Assists in training of laboratory personnel

Perform routine testing to support the release of finished product, raw materials, API as needed

Qualification

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CGMP EnvironmentLaboratory InstrumentsHPLCGCICICPFTIRUVWet Bench MethodsLean Leader5SRoot Cause AnalysisFishbone5 WhyIs/Is Not