Principal Scientist-Quality Control, Instrumentation

Catalent•Madison, WI

1d•Onsite

About The Position

Monitor and coordinate instrument installation and maintenance. Operate basic, moderately complex, and complex cGMP Quality Control equipment. Manage all aspects of laboratory equipment lifecycle. Manage all aspects of equipment vendor management. Prioritize and schedule activities to meet deadlines. Interact as an SME for internal and external entities. Lead training of specific analytical instruments and processes. Perform self-review of analytical data for accuracy and consistency with SOP. Perform general lab housekeeping in adherence to 5S standards. Complete routine and preventive maintenance on basic, moderately complex, and complex equipment. Participate in team meetings and/or training sessions. Write technical documents. Maintain and troubleshoot Quality Control equipment. Perform the foregoing using Lean Six Sigma Clean room procedure, aseptic technique, and general lab equipment experience cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) following standard operating procedures (SOP)

Requirements

Requires a Bachelor’s degree in Pharmaceutical Sciences or Related Field and 8 years of experience in job offered or 8 years of experience in the Related Occupation
Chemist or any other job title performing all listed job duties.
cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) following standard operating procedures (SOP)
Use of Agilent, Waters, and Thermo HPLC/UHPLCs (with VWD, MWD, DAD, CAD, ELSD)
Use of LC/MS
Use of GC
Use of Sciex PA800 Plus (including LIF detector)
Use of Protein Simple iCE3 and Maurice
Use of Biotech and Molecular Devices Plate Washers and Plate Readers
Use of Applied BioSystems 3500xL
Use of Applied BioSystems 7500 Fast
Use of Controlled Temperature Units (multiple vendors)
Use of pH Meters (multiple vendors)
Use of Balances (multiple vendors)
Use of Pipettes (multiple types and multiple vendors)
Lean Six Sigma
Clean room procedure
Aseptic technique
General lab equipment experience

Responsibilities

Monitor and coordinate instrument installation and maintenance.
Operate basic, moderately complex, and complex cGMP Quality Control equipment.
Manage all aspects of laboratory equipment lifecycle.
Manage all aspects of equipment vendor management.
Prioritize and schedule activities to meet deadlines.
Interact as an SME for internal and external entities.
Lead training of specific analytical instruments and processes.
Perform self-review of analytical data for accuracy and consistency with SOP.
Perform general lab housekeeping in adherence to 5S standards.
Complete routine and preventive maintenance on basic, moderately complex, and complex equipment.
Participate in team meetings and/or training sessions.
Write technical documents.
Maintain and troubleshoot Quality Control equipment.