Senior Scientist - Gainesville, United States - Kelly

    Kelly background
    Description

    Senior Analyst, QC Microbiology

    Kelly Science has a new opportunity for a Senior Analyst in the QC Microbiology group for one of our growing clients in the Gainesville/Alachua FL area. This is a temp to hire position with room for growth within the organization.

    Location: Gainesville/Alachua FL

    Shift: Monday-Friday with some flexibility for weekend or overtime depending on the business needs

    Hourly Pay: $38-$48/hour DOE

    Position Summary and Requirements:

    • Performs sampling and testing on a range of samples, finished products and stability samples
    • Verifies and approves QC data, while monitoring for trends and abnormalities. Reports, and acts on data results.
    • Serves as QC lead for investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling and testing.
    • Leads project work and investigations.
    • Serves as the technical leader in the laboratory.
    • Serve as SME (subject manager expert) for certain microbial techniques/instrumentation/equipment/procedures
    • Develops and validates new methods and processes.
    • Assist in the development of QC Microbiology analysts and technician through mentoring and training.
    • Complete deviations and Environmental monitoring trend reports
    • Compendial Endotoxin Testing

    Requirements:

    • Bachelor's degree in microbiology (or closely related subjects), Higher level degree in Microbiology preferred
    • Experience in a sterile manufacturing pharmaceutical laboratory.
    • Proficiency with instrumentation including isolator.
    • Working knowledge of cGXP requirements and a strong familiarity with production operations.
    • Proven proficiency in solving complex problems and elucidating root causes for investigations
    • Strong technical writing skills, proficiency with MS Word and Office
    • Strong familiarity with USP and EP as it pertains to Microbiology
    • Preferred Experience: Coaching and mentoring peers.