Quality Control Analyst (San Mateo)

QC Analyst – (Contract) – Greater Bay Area, CA – Onsite Biotechnology company seeks a QC Analyst II for a 10-month long onsite contract opportunity in the Greater Bay area. The ideal candidate will have 2+ years’ experience in microbiological, biological, and chemical method execution within GMP regulated environments. This person will be responsible for Environmental Monitoring and Microbiological Testing in GMP aseptic and non-sterile manufacturing cleanrooms to include high-potency API operations. Additionally, they will perform environmental monitoring and utility sampling, while upholding aseptic practices, data integrity (ALCO/ALCOA+), and safety controls for potent compounds. This candidate must have prior experience with aseptic manufacturing principles, pharmaceutical water systems, environmental monitoring programs, and QC laboratory testing experience.

Benefits Hourly pay of $33/hr. W2 to $40/hr. 1099 A long-term contract with potential extensions.

Requirements BS in Microbiology, Biology, or related pharmaceutical biotechnology area is required. 2+ years of microbiological, biological, and chemical method execution within a GMP environment, including solid cGMP technical training and troubleshooting expertise. Expertise with aseptic manufacturing principles, pharmaceutical water system, and environmental monitoring programs. Prior experience within QC lab testing. Must reside locally and within driving distance to Fremont area client site. Must be willing to be onsite 5 days a week.

Responsibilities Performing environmental monitoring, sampling, and analysis of production clean zones using particle counters, contact plates, swabs, and microbial air samplers. Performing utility water sampling and testing to include conductivity, TOC, bacterial endotoxins, and bioburden. Performing microbiological testing like microbiological examination, endotoxin, growth promotion and more. Performing sample log-in, assignment of sample tracking number, and coordination of shipment of samples to outside test labs. Performing QC lab testing accurately, according to schooled needs, and as written per procedural documentation. Ensuring all data observations and QC results are accurate. Accurately documenting all data in assay worksheets, lab notebooks, and electronic lab systems (like LIMS) in accordance with ALCO+ data principles and cGMP guidelines. Working independently and collaboratively within the QC department and cross-functional teams. Supporting aseptic process validations and gown certification processes in coordination with manufacturing staff and Quality Assurance. Performing enumeration, characterization, and speciation of microorganisms recovered from samples. Providing ongoing lab maintenance and support in support of cGMP compliance. Responsible for completing/reviewing data packets, test procedures, SOPs, and other controlled documentation in a detailed and accurate manner.