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LIMS QC Systems Support

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

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

 

Position Summary:

Perform QC lab testing and support the QC Lab in regards to LIMS support and Stability System support.

 

Main Accountabilities:

  • Perform all work in compliance with company quality procedures and standards.
  • Performs other duties as assigned.
  • Utilize and troubleshoot LIMS (LabVantage); participate and/or led LIMS (Labvantage) maintenance and validation activities
  • Collaborate with the LIMS team, IT department, and LIMS (LabVantage) users to ensure new functionality meets user requirements.
  • Write test scripts for new LIMS (Labvantage) functionality and participate in the validation of new functionality releases.
  • Support the expansion of the LIMS (Labvantage) platform through the preparation and execution of test cases for system validation.
  • Revise or develop LIMS (Labvantage) functional requirement specifications and user requirement specifications as well as other relevant documentation with guidance.
  • Responsible for scheduling of raw materials, intermediates, environmental monitoring samples, and finished goods submitted to the laboratory with minimal management oversight. Identify and implement initiatives for increasing lab efficiency.
  • Leads and executes laboratory, nonconformance, and CAPA investigations as assigned by management in compliance with procedures.
  • Ensures laboratory is functioning in compliance with SOPs, GLP, GMP, and HSE requirements. Perform safety and compliance audits of the laboratory and assist with or lead activities to address audit findings
  • Performs GMP review of test data to ensure that test results meet all specifications. Trend data and analyze trends. Troubleshoot laboratory issues related to assays, methods, instruments, and equipment and recommend potential corrective and/or preventive actions and implements within the laboratory. May execute testing as assigned by management.
  • Leads and executes method transfers, method validations, and cross-functional projects with minimal supervision. Author technical documentation, assist in review of technical documents, and provide technical support. Recommend and implement revisions to standard operating procedures.
  • Maintains personal training file. Responsible for training of other analysts as directed by management.

 

Studies and Experience:

  • Bachelor’s degree in scientific field, Microbiology degree preferred.
  • 2+ year experience working with a LIMS system (Labvantage).
  • 5+ year experience with QC laboratory test methods and test practices.

 

Skills and Qualifications:

  • LIMS (LabVantage) knowledge.
  • QC System knowledge.
  • Computer system knowledge.
  • Microbiology testing knowledge.
  • Strong communication skills and ability to work with multiple groups inside the company.

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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