Quality Assurance Tester II (Temporary)

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Pacheco, CA
1-3 Years Experience
Biotech
The Role

Our Company

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.


The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare medical is headquartered and has manufacturing facilities in California and has a global distribution network.

Summary/Objective

Responsible for executing and recording Instrument QC testing and Instrument Batch record completion activities in support of Instrument Manufacturing. This is a temporary role ending December 2024.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Perform Quality Control Testing on various instruments as directed by management or according to the established QC process.
  • Keeps an updated inventory of reagents and slides for Instrument QC testing.
  • Reviews and interprets data for accuracy, and completes all necessary documentation related to both above activities as required by company’s Quality Management System or verbal direction.
  • Prepares final test reports, including repeating and resolution of testing issues.
  • Collaborate cross-functionally to troubleshoot testing related nonconformances and root cause analysis for instrument testing.
  • Assists in general lab environment and operations maintenance.
  • Other duties as assigned by Management.

Competencies

  • Bachelor’s Degree with scientific/engineering discipline and/or three years of medical device industry Quality control experience.
  • Excellent technical writing and verbal communication skills.
  • Ability to work in a high-pressured deadline-oriented environment.
  • Attention to detail and good organizational skills.
  • Demonstrates independent judgement in resolving problems and making recommendations with proactive approach.
  • Basic computer Literacy required.
  • Basic understanding of FDA, GMP, ISO13485 and its application to the job.

Compensation Range

  • $30.00 - $34.00 hourly

Expected Hours of Work

  • 8:00 a.m. to 5:00 p.m. Monday – Friday. This position may require extended weekday or weekend hours depending on business needs.

Full-Time Positions Offer

  • Company Sponsored Health Insurance - medical, dental, vision,
  • Company Sponsored Life Insurance
  • Voluntary Benefits
  • Retirement plan - 401(k)
  • PTO
  • Paid Holidays

BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.

Proof of at least one FDA EUA approved Vaccination for Covid-19 preferred. (Subject to reasonable accommodation)

All inquiries strictly confidential.

The Company
HQ: Pacheco, CA
236 Employees
On-site Workplace
Year Founded: 1997

What We Do

Biocare Medical LLC is an innovator in automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC and in situ hybridization (ISH; RISH) testing. Biocare pioneered multiplex IHC detection which accelerates turnaround time, increases instrument productivity and reduces reagent consumption and cost by 50% or more.

Multiplex IHC allows pathologists to visualize more than one marker on a tissue at a time, allowing higher confidence for critical differentiation.

Biocare's intelliPATH FLX is the only completely open, continuous random access IHC instrument available.
The company’s customers come from clinical and research environments that do tissue based testing and include histology laboratories, pharmaceutical and biotechnology companies; CROs; and academic, government and military labs. Biocare Medical offers an expanding portfolio of products for the rapidly growing cancer and infectious disease diagnostic and research markets. Biocare medical is headquartered and has manufacturing facilities in Concord, Calif., and has a global distribution network. See biocare.net and slidestainer.com for more information.

NOTE: Biocare Medical, the Biocare Medical logo, and intelliPATH are trademarks of Biocare Medical LLC.

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