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QC Biochemistry Analyst 3 - Day Shift

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

A world leader in the field of in vitro diagnostics for more than 60 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 6,200 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.

Description

Position Summary & Responsibilities:

The normal working hours for this position are 7:00am - 7:30pm working a 2-2-3 rotation schedule. 

The QC Biochemistry Analyst 3 role is responsible for routine Biochemistry testing and participation as a subject matter expert for laboratory instrumentation and processes.

  • Leadership
    • Serves as a subject matter expert for Quality Control instruments and processes.
    • Provides guidance and input as a certified co-investigator for Laboratory Incident Reports.
    • Leads as a mentor and trainer for Quality Control testing, instrument maintenance, investigational writing, and other laboratory processes.
    • Troubleshoots simple to moderate Biochemistry laboratory equipment related issues.
  • 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 a timely manner.
    • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
    • Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas
      • Preparation includes review of logbooks for completion, instrument calibration checks, checking material expirations, and general cleanliness of laboratory area.
    • Participates in regulatory audits as a subject matter expert as needed.
    • Executes laboratory, non-conformance, and CAPA investigations as assigned by management in compliance with procedures.
    • Maintains status as a certified investigator for Out of Specification investigations.
    • Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
  • 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.
    • Recommends and authors revisions to QC department standard operating procedures (SOPs) and executes in implementation.
    • Ensures personal training is maintained to current department processes and procedures.
    • Trains and mentor’s teammates on Biochemistry laboratory testing, processes, and procedures.
    • Maintains status as a certified trainer for laboratory testing processes.
  • Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
  • Continuous Improvement
    • Participate in continuous improvement activities.
      • Identify areas of deficiency and implement practices to improve employee safety, ergonomics, workflow/process design, etc.
      • Lead improvement initiatives as directed by management.
    • 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner at all times in compliance with cGLP.
  • Other Duties
    • Work with other departments and assist with executing validation protocols associated with Biochemistry laboratory equipment, associated software, and procedures including revalidation as scheduled or required to maintain systems in a validated state.
    • Performs additional job-related duties as assigned by management.

Education, Skills, & Experience:

  • Bachelor's degree with 4+ years of experience in a regulated laboratory environment, Chemistry or Biochemistry lab experience is highly preferred.
    • In lieu of a Bachelor’s Degree, a high school diploma/GED with 8+ years of experience OR an Associate’s Degree with a minimum of 6+ years of experience working in a regulated laboratory environment are also accepted
    • Technical writing experience is highly desired - Nonconformance, Laboratory Investigative Reports, CAPAs, Deviations, and SOPs
    • Experience troubleshooting equipment and instrumentation is highly preferred (HPLC, GC, PH, UV-VIS, or similar)
  • Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
  • Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
  • In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
  • Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).
  • Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.
  • Experience with applicable instrumentation and troubleshooting.

#LI-US

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

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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