We are searching for Quality Control Analysts at several levels, for a trusted drug development and manufacturing CDMO in the Bay Area to perform microbiological testing and environmental monitoring of clinical manufacturing process samples.
Requirements for the Quality Control Analyst:
- Bachelor’s Science in a related field and minimum
- 2-8 years QC experience in a cGMP environment
- Understanding of relevant regulatory guidelines including FDA, EU, ICH, USP
- Strong knowledge of contamination control principals, method development and qualifications
- Ability to exercise excellent quality control judgement and assess and resolve complex issues effectively.
- Ability to manage multiple projects and work cross functionally and collaboratively in a dynamic, fast paced environment.
- Experience with risk management.
- Excellent verbal and written communication skills.
Responsibilities of the Quality Control Analyst:
- Coordinate and execute environmental and critical utility monitoring program for the manufacturing site.
- Utilize Bioburden, Conductivity, TOC, and Endotoxin per USP guidelines for microbiological testing.
- Conduct technical assessments and investigate deviations.
- Conduct routine trend analysis of environmental monitoring data and prepare trend reports.
- Develop, implement and maintain general laboratory operational systems in accordance with cGMP requirements.
- Write SOPs, technical protocols and reports and revise as needed.
- Collaborate with the quality control management team to ensure the quality, compliance and efficiency of QC operations.
- Ensure a safe laboratory working environment.
- Ensure contamination control principals literature and technologies remain current and up-to-date.