One our large pharmaceutical clients is looking to hire a Quality Lead to help build out a metrology program from the ground up and drive implementation of a tool (Blue Mountain software) for tracking, scheduling, and documenting the calibration activities and inventory. This individual will be supporting an external contract manufacturing organization producing a Phase Ib clinical CAR-T program.
Main responsibilities will include:
-Setup calibration, testing, repair, inspection, and maintenance of equipment
-Schedule, manage, host calibration and validation vendors
-Responsible for asset management - Helping with onboarding and relocating system, Tagging of systems, etc.
-Responsible for calibration project management stickers, schedule, overseeing outside contractors ensuring compliance, coordination of system owners, cert management, as well as the review of results/documents from vendor performed calibrations
-Recommends and initiates activities to ensure area and equipment are maintained in a state of compliance
-Initiates and documents calibration deviations and out of tolerance events
-SME for calibration activities
-Performs equipment troubleshooting and repair
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-Degree in a Science / Engineering related field required, with preferred focus or experience in pharmaceutical manufacturing
-Minimum 5 years' experience in pharmaceutical manufacturing environment
-Strong experience within metrology, validation, and calibration of pharmacuetical manufacturing equipment
-Hands on experience, or exposure to the implementation of a metrology/validation program
-Experience working with CMO, CDMO, or start up envrionments
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.