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Position Summary & Responsibilities:

The normal working hours for this role are 2nd shift from 3:00pm - 11:30pm Monday - Friday. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC EM Analyst 1 will be in a key position in the EM laboratory performing testing of bioburden, environmental sampling/testing of water, surface, air, personnel, and cleaning.

+ Quality

+ Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.

+ Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.

+ Maintains compliance with SOPs, GLP, GMP, and HSE requirements.

+ Prepares for regulatory, customer, and internal audits of EM laboratory areas.

+ Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.

+ Provides input for laboratory investigations and documents invalid test results in compliance with procedures.

+ Documentation/Training

+ Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.

+ Ensures personal training is maintained to current department processes and procedures.

+ Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.

+ Continuous Improvement

+ Participate in continuous improvement activities.

+ 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.

+ Other Duties: Performs additional job-related duties as assigned by management.

Education, Skills, & Experience:

+ Bachelor's degree in related field (e.g., Biology, Microbiology, Chemistry, Biochemistry, or other life science discipline) with 0+ years of relevant experience required.

+ In lieu of a Bachelor’s Degree, a high school diploma/GED with a minimum of 4+ years of progressively responsible experience working in a regulated laboratory environment, GMP preferred OR an Associate’s Degree with a minimum of 2+ years of progressively responsible experience working in a regulated laboratory environment, GMP environment also accepted

+ Technical and scientific knowledge working with relevant EM and/or microbiology laboratory techniques and quality principles (GMP/GLP) preferred.

+ Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills preferred.

+ Experience with EM and/or microbiology testing, knowledge of USP and EP/BP method/validation regulations preferred

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