QC Supervisor, Raw Materials
Impax Laboratories - Hayward, CA

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Responsibilities:
  • Supervise the Raw Material groups laboratory testing of Raw Materials:
  • Supervise the Validation/verification of Compendia and technical transfer of non-compendia methods
  • Co-ordinate and provide information for tests performed by contract laboratories
  • Review USP supplements and assist in implementing the required changes
  • Provide support to other Impax Laboratories sites (Taiwan)
  • Initiate CCF for SOPs, specifications and test procedures/methods
  • Train new analysts within the Quality Control laboratory
  • Write performance reviews of analysts
  • Provides technical direction and support for troubleshooting problems with testing methods or instrumentation, using good scientific principles
  • Serve as Primary source to independently conduct investigations including experimental design of investigation, any experiments, and ensuring scientific and regulatory defensibility
  • Establish the testing schedules for direct reports
  • Ensure that group members follow all applicable SOPs, Methods, and protocols as written
  • Ensure that testing documentation is complete and meets cGMP requirements
  • Ensure the group’s training is maintained
  • Write / review technical reports and laboratory investigations
  • Update / write SOPs as required
  • Provide mentorship to Chemists
  • Ensure that the laboratory and office area are maintained in a state of cleanliness and compliance
  • Other duties as assigned

Requirements:
  • B.S. or M.S. degree in Chemistry or Pharmaceutical Science
  • 5 years progressive analytical laboratory experience with majority in pharmaceutical industry including 2 years as a Senior Chemist in Quality Control laboratory
  • Strong leadership, organization and interpersonal skills
  • Excellent theoretical knowledge of analytical chemistry.
  • In-depth understanding of compendia (USP, BP, EP) requirements, regulations and standards for pharmaceutical testing.
  • Must have good verbal and written communication skills.
  • Project management skills / experience preferred.

Physical Requirements and Working Conditions:
Requires the ability to sit and work on a computer for long periods, stand, walk, communicate via telephone, computer and/or face-to-face contact, vision sufficient to monitor and use basic office equipment such as a personal computer, telephone, copier and FAX machines regularly in the course of work. Work is performed in an office environment. Noise level in this environment is within a normal range.

IMPAX Laboratories - 16 months ago - save job - copy to clipboard - block
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