Laboratory Instrumentation Specialist - Biochemistry

Scientific/R&D Durham, North Carolina

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Position Summary:

The Laboratory Instrumentation Specialist, Biochemistry is responsible for developing subject matter expertise in the operation, maintenance, data capture and troubleshooting of biochemistry laboratory equipment used to perform HPLC, gas chromatography, spectrometry, Osmolality, pH, etc.  

Primary Responsibilities:

  • Acts as a single point of contact for resolving biochemistry laboratory instrument related issues.
  • Investigates equipment related issues and helps facilitate and implement corrective and preventative actions.
  • Drafts, reviews and approves documentation related to laboratory instrumentation operation and maintenance. Generates and maintains documentation consistent with cGMP and GDP,  including electronic document systems.
  • Identifies out of trend or atypical instrument results and supports initiated/on-going investigations; Collects and helps with analysis of QC department biochemistry instrument metrics.
  • Acts as a Subject Matter Expert (SME) for QC department laboratory instrumentation, its associated documentation and generated data for internal and external audits.
  • Assists upper-level management in new endeavors including efficiency efforts, organizational tasks, and non-routine activities that require a higher level of scientific skills and regulatory expertise.
  • Interacts collaboratively and communicates effectively with QC department laboratory managers, analysts and other site departments (ie. industrialization, R & D, Engineering) to provide equipment training and troubleshoot equipment issues.
  • Participates in required training activities.
  • Carries out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with applicable requirements.

Education, Skills, and Experience:

  • BS/MS in Microbiology, Chemistry, Biology, Biochemistry or related scientific field with 3+ years of technical and scientific experience working with equipment (ex. Agilent, Waters, PerkinElmer, or similar)
  • Experience in a cGMP environment strongly preferred.
  • Experience working with LIMs systems.
  • Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers
  • Expertise in cGMP analytical and biochemistry laboratory  testing instrumentation maintenance and troubleshooting.
  • Experience working in an FDA regulated, GMP environment with knowledge of Good Documentation Practices is required.

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ 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).