DescriptionThe estimated salary range for this role based in California is between $87,200 and $104,600 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieuxs bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidates experience and will be presented in writing at the time of the offer.
In addition, bioMrieux offers a competitive Total Rewards package that may include:

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves

Primary Duties

• Conducts routine QC testing of incoming raw material, finished goods, and stability products.
• Manage QC testing schedule alongside production schedule to ensure timely closure of work orders.
• Document results, issues, and other relevant information using good documentation practices (GDP) under the site Quality Management System.
• Reviews production batch records and QC test results for accuracy, completeness, and GDP.
• Supports and executes protocols for analytical test methods and aids in the transfer of methods to QC.
• Analyzes, prepares, and communicates data findings, trends, non-conformances, and deviations.
• Assists as needed with investigations to determine root cause of non-conformances.
• Maintain lab equipment compliance by ensuring preventative maintenance and calibrations are completed on time.
• Supports environmental monitoring of production spaces.
• Performs subculture of organisms required for testing, ensuring organism availability.
• Run instrumentation including, but not limited to UV-Vis and FTIR spectrophotometers, and microbiological diagnostic equipment.
• Maintains inventory and orders lab supplies as needed.
• Practices good lab safety according to OSHA/EHS regulations and Good Laboratory Practice (GLP), as well as other applicable regulations.
• Updates QC procedures and/or specifications as needed.
• Ensures cleanliness of QC laboratory
• Trains new team members as needed.

Knowledge, Experience, and Skills

• BS in biology, chemistry or related scientific field and a minimum of 3 years relevant laboratory experience.
• Good hygiene and aseptic practices, with experience working with hazardous chemicals and microorganisms.
• Medical Device or other FDA regulated industry experience required. Must possess working knowledge of good laboratory practices, GMP, and antibiotic/microorganism interactions.
• Must possess effective written and verbal communication skills. Must possess ability to read and interpret common scientific methods, procedures, and regulatory guidelines.
• Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
• Self-motivated, highly organized, with ability to multitask and open to learning new skills. Must be able to work in a team environment, building effective working relationships..