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.

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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.

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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

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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.

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Education

Minimum Required:

• Bachelor of Science in Microbiology, Biology, or a related pharmaceutical biotechnology discipline

 
 
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.