Curium Pharma · 3 days ago
Senior Quality Control Testing Engineer
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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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Required
Bachelor of Science Degree in Chemistry, or other science related field, preferred.
5 or more years of relevant experience in a cGMP environment required.
Extensive knowledge of laboratory instruments/methods such as HPLC, GC, IC, ICP, FTIR, UV, wet bench methods, etc.
Preferred
Lean Leader/Operational Excellence/5S
Root Cause Analysis tools (Fishbone, 5 Why, Is/Is Not, etc.)
Benefits
Health Insurance
Company
Curium Pharma
Curium is a world-class nuclear medicine solutions provider with over 100 years of industry experience.
Funding
Current Stage
Late StageTotal Funding
unknown2017-04-06Acquired· by CapVest
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