QC Environmental Monitoring (EM) Analyst 1 – 2nd Shift Position Available In Durham, North Carolina

QC Environmental Monitoring (EM) Analyst 1•2nd Shift bioMerieux SA•3.7

Durham, NC Job Details Estimated:

$58.8K•$70.6K a year 8 hours ago Qualifications CGMP Microbiology GLP Laboratory experience GMP Mid-level High school diploma or GED Bachelor’s degree Laboratory techniques Data entry Technical writing Associate’s degree FDA regulations Under 1 year

Full Job Description Description 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. 6

S:

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 #biojobs