We have an open METHOD VALIDATION /
ANALYTICAL CHEMIST III position in our Quality Control Department in the Irvine, CA location.
PRIMARY DUTIES AND RESPONSIBILITIES:- Perform method validation, verification, transfer, analytical testing for clinical submission materials, including raw materials, finished products, stabilities and cleaning validation.
- Maintain and troubleshoot analytical instrumentation.
- Perform and document laboratory investigations, as necessary.
- Peer review data generated by other chemists and technicians.
- Develop, validate and troubleshoot analytical methods.
- Conduct method transfers from other facilities and departments.
- Author standard operating procedures and analytical methods.
- Perform and/or assist with equipment calibrations and qualification.
- Assist laboratory management with laboratory employee training.
- Assist laboratory management in preparation for internal, customer and agency audits.
- Other related duties as required.
QUALIFICATIONS:- Bachelor's degree in chemistry or related discipline.
- 5+ years' experience in a chemistry laboratory, or equivalent combination of education and experience.
- 5+ years' experience with analytical instrumentation, such as HPLC, GC, CE, ICP, FTIR, and dissolution apparatus required.
- 2+ years' experience in GLP or GMP (preferred) environment.
- Ability to follow standard operating procedures.
- Strong communication skills, both written and verbal.
- Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
- Strong attention to detail.
