Role Description

The Quality Operations Laboratory Analyst supports routine testing and review of microbiology data in a GMP environment. This individual will be responsible for a variety of microbiological assays including microbial limits testing, bacterial endotoxin, sterility testing, growth promotion, and environmental monitoring.

RESPONSIBILITIES:

• Works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze raw materials, qualified utilities, APIs, and/or finished product samples in support of the company's quality program in the microbiology laboratory.
• Performs environmental monitoring.
• Supports microbiological programs including release/stability testing, sanitization/sterilization validation, media prep, and growth promotion.
• Performs, documents, record checks, and troubleshoots qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation.
• Interprets and evaluates data in terms of accuracy, precision, trends, and potential GMP impact and recommends appropriate corrective action where necessary.
• Participates in laboratory investigations as required.
• This position may also be responsible for writing routine protocols or conducting assay, process, or instrument qualifications.
• The applicant may train others as skills and knowledge allow.

EXPERIENCE REQUIRED:

• The successful candidate must have demonstrated proficiency in aseptic technique and GLP/GMP laboratory.
• The successful candidate must also have demonstrated the ability to quickly learn new skills/techniques.
• High productivity and the ability to multi-task coupled with a low error rate and attention to detail are critical characteristics of this position.
• Must demonstrate flexibility/agility and engagement in a changing environment.
• The candidate is expected to display good laboratory technique to avoid cross-contamination or misidentification of samples.
• Able to comprehend and perform both routine and non-routine analyses from compendial and internal sources.

QUALIFICATIONS:

• AAS or BA/BS in Microbiology, Biology, or related science preferred.
• Previous QA/QC experience in a GMP Pharmaceutical manufacturing environment desired.
• These positions may require colleagues to work weekends and/or holidays to meet business or customer needs.
• NOTE: Candidate must not be cephalosporin/penicillin sensitive.