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QC Analyst I, Cell Therapy
4 months ago
We are seeking a Quality Control Analyst I for our CDMO based in Alameda, specializing in cell and gene therapies. The analyst will play a crucial role in ensuring the consistent quality of our cell manufacturing processes. Key responsibilities include performing environmental monitoring, managing inventory, and conducting data trending. Additionally, you will review and maintain GMP documentation related to SOPs, testing methods, and protocols.
Responsibilities
- Execute and document laboratory procedures, ensuring adherence to Good Documentation Practices (GDP).
- Conduct Quality Control (QC) Environmental and Utilities Monitoring.
- Perform and record plate readings accurately.
- Carry out growth promotion testing.
- Assist in the review and analysis of data.
- Maintain monthly housekeeping standards, including thorough equipment cleaning.
- Manage inventory efficiently to support laboratory operations.
- Oversee microbial identification processes and ensure accurate record-keeping.
- Collaborate effectively with Manufacturing, Quality Assurance, Facilities, and Supply Chain teams.
Qualifications
- B.S. degree in Biology or a related field with experience in cell therapy and microbiology.
- 0-3 years of industry experience for QC Analyst I; over 3 years for more advanced positions.
- Proficient in MS Word, Excel, Project, and PowerPoint.
- Availability to work extended hours and weekends as needed to meet deadlines.
- Comfortable working in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.
- Self-motivated, detail-oriented, and willing to take on temporary responsibilities outside of the initial job description.
Nice to haves
- Proficient in performing relevant QC microbiological assays.
- Experienced in working within Good Manufacturing Practice (GMP) environments.
- Familiar with operations in contract laboratories and Contract Development and Manufacturing Organizations (CDMOs).
- Knowledgeable in using Laboratory Information Management Systems (LIMS).
- Experienced in gene and cell therapies or the pharmaceutical industry.
