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Quality Control Scientist

Company: BioFire Diagnostics
Location: San Jose
Posted on: January 25, 2023

Job Description:

The CompanyThe world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. The sepsis mortality rate increases > 6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.Specific Diagnostics, a bioMerieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for the bloodstream and other acute infections. Used for bloodstream infection Specific's solution provides results 2 days sooner (1 day vs 3 days).We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.Position Summary QC scientist works in a cGMP environment performing quality control testing for commercial diagnostics products. Responsibilities include inspection and testing of products to approved specifications according to approved processes and procedures. Works closely with the sensor manufacturing team to maintain production schedule, elevate quality issues, and ensure quality of production batches. Performs all duties using quality mindset and safety conscious practices. Primary Duties

  • Conducts routine chemistry testing of incoming raw material, finished goods, and stability products.
  • Manage QC testing schedule alongside production schedule to ensure timely closure of work orders.
  • Document results, issues, and other relevant information using good documentation practices (GDP) under the site Quality Management System.
  • Reviews production batch records and QC test results for accuracy, completeness and GDP.
  • Supports and executes protocols for analytical test methods and aids in the transfer of methods to QC.
  • Analyzes, prepares and communicates data findings, trends, non-conformances, and deviations.
  • Assists with investigations to determine root cause of non-conformances.
  • Maintain lab equipment through ensuring preventative maintenance and calibrations are completed on time.
  • Run instrumentation including, but not limited to microarray printer, inkjet printer, UV Visible spectroscopy, FTIR, and other various wet chemistry analyses.
  • Must possess ability to read, analyze, and interpret common scientific and technical journals, scientific procedures and regulatory guidelines.
  • Maintains inventory and orders lab supplies as needed.
  • Practices good lab safety according to OSHA/EHS regulations and Good Laboratory Practice (GLP), as well as other applicable regulations.
  • Updates QC procedures and/or specifications as needed
  • Ensures cleanliness of QC laboratory
  • Performs other duties as assigned.QualificationsTraining and EducationBS in chemistry or related field and a minimum of 1 year experience working in a regulated cGMP environment Experience
  • For level 10: BS in chemistry or related field and a minimum of 1 year experience
  • For level 9: BS in chemistry or related field and a minimum of 3 years' experience
  • Excellent chemical hygiene, experience working with hazardous materials.
  • Medical Device or other FDA regulated industry experience required
  • Must possess effective written and verbal communication skills.
  • Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
  • Working knowledge of common laboratory practices
  • Self-motivated, highly organized, with ability to multitask and open to learning new skills.Knowledge, Skills, and AbilitiesMake decisions based on defined guidelines and procedures. Performs a wide variety of inspection and audit root cause analysis and applies problem solving skills to determine root causes and appropriate corrective actions. Is empowered to make decisions impacting product quality, quality records, and deviation resolution.

Keywords: BioFire Diagnostics, San Jose , Quality Control Scientist, Other , San Jose, California

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