- 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
- 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 - 18 months ago