Job Title: QC Analyst II Location: Newark, California Duration: 10 months Position Summary The QC Analyst II is responsible for environmental monitoring (EM) and microbiological testing in a GMP aseptic and non-sterile manufacturing cleanrooms, including high-potency API operations. Perform environmental monitoring and utility sampling while upholding aseptic practices, data integrity (ALCO/ALCOA+), and safety controls for potent compounds. Key Responsibilities Perform environmental monitoring, sampling, and analysis of production clean zones using particle counters, contact plates, swabs, and microbial air samplers. Perform utility water sampling and testing (conductivity, TOC, bacterial endotoxins, and bioburden) Perform microbiological testing such as microbiological examination, endotoxin, growth promotion, etc. Perform sample log-in, assignment of sample tracking number, and coordinate shipment of samples to outside test labs. Perform QC Laboratory testing accurately, according to schedule, and as per written procedures. Record all data, observations, and QC results accurately with attention to detail. Accurately document all data in assay worksheets, laboratory notebooks, and electronic systems (e.g., LIMS) in accordance with ALCO+ data principles and cGMP guidelines Other duties as assigned. Work independently as well as collaboratively within the QC department and cross-functional departments. Support aseptic process validations and gown certification processes in coordination with manufacturing staff and Quality Assurance. Performs enumeration, characterization, and speciation of microorganisms recovered from samples. Provide lab maintenance and support to ensure cGMP compliance on a regular basis. Take full responsibility in completing/reviewing data packets, test procedures, SOPs, and other controlled documents in a detailed and accurate fashion. Qualification & Experience At minimum, 2+ years of microbiological, biological, and chemical method execution within a GMP environment. Experience with aseptic manufacturing principles, pharmaceutical water system, and environmental monitoring programs. Previous cGMP, solid technical training, and troubleshooting experience. Competencies: Integrity, Trust, Ethics & Values Results oriented Strategic Skills Organizing/Priority Setting Business Acumen Planning Decision Quality Customer focused Conflict Management Interpersonal Savvy Negotiating Problem Solving Listening & Approachability Partnering Working Conditions & Physical Demands Prolonged periods of standing and/or sitting at a workstation Must be able to regularly lift and/ or move up to 25 pounds Specific vision abilities include close vision, distance vision, color vision, peripheral vision, and depth perception. Education Minimum Required: Bachelor of Science in Microbiology, Biology, or a related pharmaceutical biotechnology discipline Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 42.00/hr.