Real Staffing is looking for a QC Analyst to join a QC team in Berkeley. The Quality Control Analyst will have the opportunity to coordinate and collaborate with other cross-functional departments, including Analytical Development, Process Development, Quality Assurance, Facilities, Procurement, etc. This position will also provide a learning/growth opportunity to execute various quality systems, such as document change request, lab investigations, change controls, specification writing, analytical report writing and method qualifications.
- Analytical methods include but not limited to FTIR, A280, HPLC and wet chemistry methods.
- Perform raw materials testing, in-process, release testing and stability of drug substance and drug product
- Document deviations, assist in determining root cause and apply CAPA.
- Maintain lab compliance by performing routine housekeeping, including stocking of lab supplies, sample management and compliance to safety regulations
- Prepare and maintain reagents, stocks, controls per established procedures
- Support equipment maintenance and calibration
- Perform or participate in methods development/qualification
- Generate raw material specifications, as needed
- Initiate, revise and review SOP's, test methods, method qualification reports
- Excellent observation and attention to detail and accuracy for record keeping and documentation
- At least 3 years ELISA and/or HPLC experience
- Good ability to problem-solve and find creative and effective solutions
- Team work and communication are key attributes needed for this position, as this role will be part of a small team within quality control. A collaborative attitude and a positive work ethic are key traits for success.
- High motivation to meet demands and standards of the QC department and our cross-functional teams
Sthree US is acting as an Employment Business in relation to this vacancy.