QC Microbiology Analyst 3

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 revisions
• Perform 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 accepted
• Technical 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.

#LI-US