The QC Analyst II position is a highly experienced analyst position within the QC laboratory. The QC Analyst II performs testing of any and all samples submitted to the laboratory in a cGMP compliant manner. The QC Analyst II requires the least comprehensive in-house training curriculum of any analyst position in the laboratory by virtue of prior experience, although documented proficiency is required for the execution of all activities. The QC Analyst II performs all activities according to approved written procedures. Because of the level of experience associated with this position, a QC Analyst II may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance management, equipment IQ, OQ, PQ activities, reference standard inventory control, cleaning validation swab procedures, and method validation and transfer activities. The QC Analyst II will be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc. at the discretion of quality control supervisory staff.
Required Education and Experience:
- Bachelor's degree in Chemistry or related scientific field
- 3+ years of laboratory experience in a regulated environment