QO Lab Analyst II

States considered: Michigan

POSITION SUMMARY

The QO Laboratory Analyst supports routine testing and review of microbiology data in a GMP environment. The QO Lab Analyst works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze finished product samples prior to commercial release.  This is a dynamic, growing lab within a growing manufacturing site with opportunity to learn new skills and to work cross-functionally.

POSITION RESPONSIBILITIES

• Analyzes 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.
• Recommends and executes process improvements to continually improve laboratory performance.

TECHNICAL SKILLS REQUIREMENTS

• Must have demonstrated proficiency in aseptic technique.
• 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.
   

EDUCATION AND EXPERIENCE

• AAS or BA/BS in Microbiology, Biology, or related science preferred.
• Previous QA/QC experience in a GMP Pharmaceutical manufacturing environment desired.
• Preferred experience includes GMP documentation, drug product formulation, in-plant laboratory, Incoming Inspection, SAP, LIMS
• Key characteristics of a successful candidate in this position: willingness and ability to learn, ability to work in a team environment, and attention to detail.
   

SHIFT HOURS

This position may require colleagues to work weekends and/or holidays to meet business or customer needs.

PHYSICAL REQUIREMENTS

Candidate must not be Cephalosporin/Penicillin sensitive.

While performing the duties of this job, the colleague is regularly exposed to both office settings and a laboratory setting.  The work conditions for this position are 70% stationary and 30% standing and walking throughout the workday. The job duties involved occasional lifting (less than 35lbs).

Full timeRegularColleague

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