Head of Quality Control at Millipore Corporation

Posted in Other 6 days ago.

Location: Indianapolis, Indiana

Job Description:

Position Overview:Responsible for all Quality Control testing and ensures all testing activities are performed on time according to Site Quality standards and applicable regulatory requirements. This includes providing leadership to Managers/Supervisors for the Chemistry laboratory, the Microbiology laboratory, QC systems and QC validation. The laboratories and QC systems and validation teams are responsible for facility and product testing and data review / evaluation / interpretation, laboratory investigations into OOS and OOT, method validation, and method transfers. Also responsible for QC relationships with CDMO Clients. Oversees the Qualified Scientist positions responsible for analytical data quality assurance and CMO QC Client interactionsProvides leadership to QC Lab employees including the QC Systems and QC Validation teamsResponsible for managing the QC relationships with CDMO ClientsInterviews, hires, and trains employees; plans, assigns, and directs work; appraises performance; rewards and coaches employees; addresses concerns and resolves problemsResponsible for maintaining the Quality Control labs in full compliance with company policies and procedures, cGMP and current pharmaceutical laboratory best practicesAs a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes. And, the employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such trainingPerforms special projects and other duties as assigned

Who You Are:

Minimum Qualifications:

BS in Science in Chemistry / Microbiology is the minimum requirement with 10 years of experience in quality control supporting GMP/GLP manufacturing operations

Preferred Qualifications:

Master of Science or Doctoral degree (Ph.D) or equivalent in Chemistry / Microbiology / Biochemistry is preferablePrevious leadership experience required, 7 years or more previous management experience preferredMust have extensive and current knowledge of cGMPs and best industry practices in the pharmaceutical QC quality systemsStrong written and oral communication skills are required.

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