Quality Control Analyst

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 clean rooms 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.

• Hourly pay of $33/hr w2 to $40/hr. 1099
• A long-term contract with potential extensions.

• 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.

• 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.