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QC Analyst 1 Biochem - 2nd Shift

Location: Durham, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

 

Position Summary:

Executes routine tests per standard operating procedures.  Tests may be raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory.

 

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

 

Supplemental Information:

This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Analyst 1 will be in a key position in the biochemistry laboratory performing testing of Description, pH, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC. 

 

Studies and Experience:

  • BS with 0  years of relevant experience preferred.
  • High school diploma/GED with a minimum of ≥ 4 years of progressively responsible experience or an Associate’s Degree with a minimum of ≥ 2 years of progressively  responsible experience working in a regulated, GMP environment required.

 

Skills and Qualifications:

  • 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.
  • 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.

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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