Looking for several Quality Control Analysts (level I-III) to perform testing and solution preparations, equipment & instrumental calibrations and maintenance,results reporting, and test protocols as assigned by management. The analyst will also be responsible for assisting in writing protocols & reports, as well as sampling raw material, finished goods, stability samples and additional samples as assigned.
location: Pomona, California
job type: Temporary
salary: $30 - 35 per hour
work hours: 9 to 5
- Performs testing on raw material, in-process, & finished good samples.
- Prepares all solutions needed for testing.
- Performs testing on stabilities.
- Samples raw material, finished goods, stability samples and additional samples as assigned.
- Performs instrument & equipment calibrations/performance checks
- Documents all data in corresponding laboratory notebook
- Disposes of all chemicals safely
- Performs required testing pertaining to customer complaints, discrepancies, & laboratory investigations.
- Reports necessary results to production supervisors, in a timely manner
- Reviews laboratory SOPs
- Assists in the performance of qualifications and validations of instruments and test methods
- Performs impurity, supplier approval, and research testing
- Troubleshoots and maintains basic instruments
- Executes test protocols, as assigned by management
- Assists in writing protocols and reports
- Trains new employees basic laboratory skills and functions
- Perform other duties as required to fulfill department and business needs.
- BS / MS in Chemistry, Biochemistry or related discipline is preferred with 5 years of experience in a pharmaceutical industry.
- Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
- Expertise in OOS/OOT/Atypical resolution, deviations, change controls, root cause analysis, and monitoring CAPA effectiveness would be a desirable.
- Experience with an ICH compliant stability program with the ability to perform statistical analysis to identify trends.
- Experience with electronic systems such as LIMS is an advantage.
- Knowledge of relevant FDA guidance documents.
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.