Analyst, QC I
QC Analyst (Pharmaceutical)
Location: Novato, CA.
Assignment:12 months (Potential to extend)
Pay Rate: $28/hr.
On Behalf of our client a leading pharmaceutical company developing therapeutics for patients dealing with life threatening rare genetic diseases. We are seeking for a QC Analyst to join their QC Process team. The ideal candidate will perform microbiological and analytical testing to ensure compliance with cGMP guidelines, facilitate sample processing, and contribute to maintaining inspection readiness in a laboratory environment. This role involves cross-functional collaboration, proactive problem-solving, and opportunities to contribute to method validation and optimization.
Key Responsibilities:
· Manage the timely receipt, accessioning, and batch assignment of incoming samples across all assay types, adhering to best practices.
· Execute microbiological and analytical methods for in-process testing under cGMP guidelines, ensuring timely reporting of results to meet internal customer requirements.
· Perform environmental monitoring, sampling, and testing of facilities, equipment, and utilities.
· Evaluate assay validity, calculate and summarize results, and perform data analysis against specifications. Assist with compiling and verifying trend analysis reports.
· Share and complete general housekeeping tasks to maintain laboratory readiness for inspections.
· Monitor and manage laboratory supplies and critical reagent inventories.
· Conduct media growth promotion and microbial identification testing.
· Provide on-call coverage for QC laboratory equipment functionality oversight.
· Identify and communicate compliance risks or procedural deviations, initiate investigations promptly.
· Support test method validation, investigations, technical studies, and method transfer protocols.
· Participate in team meetings, generate ideas for laboratory infrastructure improvements, and contribute to method optimization.
Education and Qualifications:
· Bachelor of Science degree in a relevant field, and 1 years of relevant laboratory experience.
QC-specific experience is preferred.
· Knowledge of quality management systems, cGMP guidelines, and QC principles.
· Proficiency in certified functional activities and related documentation.
· Proficiency in Microsoft Word and Excel; experience with PowerPoint, Access, or Visio is a plus.
Please submit a copy of your resume in Word or PDF format to be considered.