The QO Lab Analyst position works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze raw materials, packaging materials, in-process materials, APIs, utilities, and/or finished product samples in support of the company’s quality program in the laboratory.
- Maintains and supports microbiological programs including release/stability testing, environmental monitoring, 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. May participate in manufacturing QC support such as cleaning verification.
- Interprets and evaluates data in terms of accuracy, precision, trends, and potential GMP impact and recommends appropriate corrective action where necessary.
- High productivity and the ability to multi-task coupled with a low error rate and attention to detail are critical characteristics of this position.
- Demonstrates 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.
- May train others as skills and knowledge allow.
- Participates in laboratory investigations as required.
- May be responsible for writing routine assay protocols or conducting assay, process, or instrument qualifications.
- The successful candidate must have demonstrated proficiency in aseptic technique and have experience with environmental monitoring
- The successful candidate must also have demonstrated the ability to quickly learn new skills/techniques.
EDUCATION AND EXPERIENCE
- AAS, BA/BS, or MS in Microbiology, Biochemistry, or related science.
- Previous QA/QC experience in a GMP Pharmaceutical manufacturing environment is preferred or a minimum of 2 years related experience in Quality Operations is preferred.
- The successful candidate must have demonstrated proficiency in at least two or more microbiological disciplines (e.g. sterility, endotoxins, microcount/bioburden/pathogens, utility testing, environmental monitoring, media preparation, microbial identification, growth promotion, etc.) as required by the business unit.
- Job duties involve occasional lifting (less than 35 lbs), reaching, and sitting while working at computer terminal.
- Candidate must not be Cephalosporin/Penicillin sensitive.