Senior Scientist

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.