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Description

Position Summary & Responsibilities:

Executes routine microbiology tests per standard operating procedures. Tests may be raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 3 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial Neutralization and Contamination Check. 

Performs routine microbiology testing of samples submitted to the laboratory.Documents all test results in compliance with procedures and GDP requirements.Maintains compliance with SOPs, GLP, GMP, and HSE requirements.Maintains laboratory equipment in compliance with procedures and GLP requirements.Responsible for inventory management and ordering/stocking of laboratory supplies.Executes laboratory, nonconformance, and CAPA investigations as assigned by management in compliance with procedures.Enters data into LIMS system. Assists with LIMS data entry to support LIMS maintenance and validation activities.Maintains personal training file. Responsible for training of other analysts as directed by management.Assists with scheduling of raw material, intermediates, environmental monitoring samples, and finished goods submitted to the laboratory as directed by management.Assists in the ordering and stocking of laboratory supplies; may have responsibility for inventory management.Provides input to laboratory investigations and documents invalid test results in compliance with procedures.Recommends revisions to standard operating procedures and assists in implementation of revisionsPerform any additional job related duties as requested.

Education, Skills, & Experience:

Bachelor's degree with 4+ years of experience in a regulated laboratory environment, Microbiology or Environmental Monitoring lab experience is highly preferred. In lieu of a Bachelor’s Degree, a high school diploma/GED with 8+ years of experience OR an Associate’s Degree with a minimum of 6+ years of experience working in a regulated laboratory environment are also acceptedTechnical and scientific knowledge working with relevant microbiology laboratory techniques and quality principles (GMP/GLP).Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).Experience with microbiological testing, knowledge of USP and EP/BP method/validation regulations, microbiological identification methods.Experience in Growth Promotion Test.

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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).