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Quality Control Scientist

Location: San Jose, CA, 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.

Description

The Company

The 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

  1. Conducts routine chemistry testing of incoming raw material, finished goods, and stability products.
  2. Manage QC testing schedule alongside production schedule to ensure timely closure of work orders.
  3. Document results, issues, and other relevant information using good documentation practices (GDP) under the site Quality Management System.
  4. Reviews production batch records and QC test results for accuracy, completeness and GDP.
  5. Supports and executes protocols for analytical test methods and aids in the transfer of methods to QC.
  6. Analyzes, prepares and communicates data findings, trends, non-conformances, and deviations.
  7. Assists with investigations to determine root cause of non-conformances.
  8. Maintain lab equipment through ensuring preventative maintenance and calibrations are completed on time.
  9. Run instrumentation including, but not limited to microarray printer, inkjet printer, UV Visible spectroscopy, FTIR, and other various wet chemistry analyses.
  10. Must possess ability to read, analyze, and interpret common scientific and technical journals, scientific procedures and regulatory guidelines.
  11. Maintains inventory and orders lab supplies as needed.
  12. Practices good lab safety according to OSHA/EHS regulations and Good Laboratory Practice (GLP), as well as other applicable regulations.
  13. Updates QC procedures and/or specifications as needed
  14. Ensures cleanliness of QC laboratory
  15. Performs other duties as assigned.


 Qualifications

Training and Education

BS in chemistry or related field and a minimum of 1 year experience working in a regulated cGMP environment
 

Experience

  1. For level 10: BS in chemistry or related field and a minimum of 1 year experience
  2. For level 9: BS in chemistry or related field and a minimum of 3 years’ experience
  3. Excellent chemical hygiene, experience working with hazardous materials.
  4. Medical Device or other FDA regulated industry experience required
  5. Must possess effective written and verbal communication skills.
  6. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
  7. Working knowledge of common laboratory practices
  8. Self-motivated, highly organized, with ability to multitask and open to learning new skills.

Knowledge, Skills, and Abilities

Make 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.

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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