QC Microbiology Analyst 1

Position Summary & Responsibilities:

The QC Microbiology Analyst 1 role is responsible for microbiological testing. The responsibilities of this position include: testing of finished product samples, stability samples, and special test requests of multiple products per standard operating procedures, preparation and manipulation of microbial cultures and stocks using aseptic technique, and Investigational writing.

• 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 an accurate and timely manner.
  • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
  • Prepares for regulatory, customer, and internal audits of microbiology laboratory areas.
  • Preparation includes review of logbooks, instrument calibration dates, material expirations, general cleanliness of laboratory area, etc.
  • 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:

• BS in Microbiology, Biology, Biochemistry, or related life science with 0+ years of relevant experience required.
• • A high school diploma/GED with 4+ years of relevant experience in a regulated environment, GMP preferred, OR an Associate’s Degree with 2+ years of relevant experience working in a regulated environment, GMP preferred are also accepted
  • Prior microbiological lab experience preferred.
  • Experience with sterile technique preferred.
• Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
• Theoretical knowledge of relevant laboratory techniques and quality principles.
• Knowledge of software tools for data entry and analysis.
• Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
• Teamwork orientation and demonstrated history of taking initiative to find and make improvements.

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