QC Microbiology Scientist

This position will work in the cGMP compliant QC Microbiology Laboratory supporting manufacture of biological products.

Responsibilities

• Perform microbiological testing (bioburden, bacterial endotoxin testing, growth promotion, biological indicators, and stock cultures), and bioburden and endotoxin validation work.
• Write and technically interpret controlled documents and reports, and review data and initiate investigations.
• Interact with other departments to ensure correct sample flow, testing, supply chain, and equipment disposition.
• Perform microbiological testing methods in a GMP Microbiology laboratory.
• Perform Bioburden and Endotoxin testing for waters, in-process, and product samples.
• Qualify microbiological testing such as bioburden and bacterial endotoxin.
• Draft SOPs, Test Records, OOS Investigations, Summary reports, and supporting documents.
• Review, analyze, and summarize data with guidance.
• Order laboratory supplies and maintain required inventory according to SOPs.
• Arrange the receipt of samples in the lab for testing.
• Maintain and ensure safe laboratory practices using aseptic techniques while handling samples.

Requirements

• Bachelor’s degree in Life Sciences or Biology is required; Microbiology is preferred.
• A minimum of 1 year of work experience within the biological and/or pharmaceutical industry is preferred. A graduate degree and appropriate hands-on college coursework may substitute at an equivalent rate for required experience.
• Hands-on experience with aseptic technique, light microscopy, gram stain, bioburden testing, bacterial endotoxin testing, and general microbiological techniques.
• Familiarity with microbial taxonomy and identification.
• Experience with laboratory documentation, reports, and quality systems (LIMS, Trackwise, Documentum).
• Must be legally authorized to work in the United States now and in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Schedule

• Wednesday to Saturday, 10-hour shift.
• Flexibility and overtime may be required on holidays and weekends to support project timelines.

Benefits

• Competitive remuneration and annual incentive plan bonus.
• Healthcare and a range of employee benefits.
• Employment with an innovative, forward-thinking organization offering outstanding career and development prospects.
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.

Relocation assistance is not provided.