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QC Analyst

Location: Berkeley, California Salary: competitive
Sector: R&D, Quality Assurance (QA) Type: Contract

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.

ESSENTIAL DUTIES:

  • 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

QUALIFICATIONS/REQUIREMENTS:

  • 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.