Jobs

Description

JOB SUMMARY

• The QC Analyst 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.
• The analyst partners closely with Manufacturing and QA to protect product quality and patient safety.
• Additional responsibilities include peer reviewing laboratory documentation for accuracy, performing routine laboratory and equipment maintenance in accordance with policies and procedures, and supporting documentation management.
• Participation in special projects and/ or instrument problem-solving as needed.
• 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.

Skills:    

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.

Education:         

Minimum Required:

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