Position Title: QC Microbiology Analyst 1
Work Location: Durham, NC
Assignment Duration: 12 Months
Work Schedule: M-F DAY
Work Arrangement: Onsite

Position Summary:
The QC Microbiology Analyst 1 role is responsible for microbiological testing. 

• 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.

Key Responsibilities:

• 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.
• Investigational writing.
• 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.
• 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.
• Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
• 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.
• Performs additional job-related duties as assigned by management.

Qualification & Experience:

• BS in Microbiology, Biology, Biochemistry, or related life science.
• Check the highest-level education required (must be job-related).
• Identify the discipline, where applicable: High School Diploma or GED, Vocational/Technical Associate’s Degree
• Bachelor’s Degree Master’s Degree Doctorate Post Doctorate
• Professional Certification
• Will work experience be accepted in lieu of a degree? Yes No
• If yes, number of years of experience accepted in lieu of degree and type:
• 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.
• BS with 0 years of relevant experience required.
• Prior microbiological lab experience preferred.
• Experience with sterile technique preferred.
• 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 ensure tasks adhere to the HSE Management System.
• Ability to remain in a 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.
• Ability to operate heavy machinery.
• Ability to adjust or move objects up to 50 pounds in all directions.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 22.00/hr.