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QC Microbiology Analyst 1
Ref No.: 25-254682
Location: Durham, North Carolina
Start Date: 06/20/2025
Job Title: QC Microbiology Analyst 1
Job Location: 100 Rodolphe Street Durham NC 27712
Job Duration: 12+Months contact
Shift: Mon-Friday 9-5/8-4 flexibility


Job Description
  • The QC Microbiology Analyst 1 role is responsible for routine Microbiology testing. The responsibilities of this position include:
  • Testing of finished product samples, special test requests, and stability per standard operating procedures.
  • Preparation and maintenance of microbial cultures and microbial manipulation for testing using microbiological instrumentation, aseptic technique, and the proper PPE.
  • Investigational writing.
1)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.
2) 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.
3) Safety
  • Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
4) 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.
5) Other Duties
  • Performs additional job-related duties as assigned by management.
Supplemental Data
This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the microbiology laboratory performing testing of Growth Performance, Antimicrobial Neutralization, Contamination Checks, and other testing duties.

Training and Education
  • BS in Microbiology, Biology, Biochemistry, or related life science.
OR
  • in lieu of a bachelor's degree, 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.
Experience
  • BS with 0 years of relevant experience required.
  • Prior microbiological lab experience preferred.
  • Experience with sterile technique preferred.
Knowledge, Skills, and Abilities
  • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
  • Excellent and effective verbal and written communication skills.
  • 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.
  • Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
  • Able to assess safety and environmental risks to ensuring tasks adhere to HSE Management System.
  • Physical Requirements:
  • Ability to remain in stationary position, often standing, for prolonged periods.
  • Ability to ascend/descend stairs, ladders, ramps, and the like.
  • Ability to wear PPE correctly most of the day.