QC Environmental Monitoring (EM) Analyst 1 - 2nd Shift

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.
  • 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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