QC Analyst 1

3 weeks ago

Durham, United States Biofire Diagnostics Full time

Position Summary:

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, and Contamination Checks. In this role you will execute routine tests per standard operating procedures on raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory.

Primary Responsibilities:

* Performs routine testing of samples submitted to the laboratory. Documents all test results in compliance with procedures and GDP requirements.
* Enters data into LIMS system. Assists with LIMS data entry to support LIMS maintenance and validation activities.
* Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
* Maintains personal training file.
* Maintains laboratory equipment in compliance with procedures and GLP requirements.
* Assists in the stocking of laboratory supplies.
* Perform any additional job-related duties as requested.

Education, Skills, & Experience:

* Bachelor's degree with 0 years of relevant experience required. BS in Microbiology, Biology, Biochemistry, or related life science.
* In lieu of a Bachelor's Degree, a high school diploma/GED with 4 years of experience in a regulated environment, GMP preferred OR
* Associate's Degree with 2 years of progressively responsible experience working in a regulated environment, GMP preferred.


* 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 ensuring tasks adhere to HSE Management System.

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