Quality Assurance Inspector I (Temporary)

| Pacheco, CA, USA
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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 performing Line Clearance activities at each phase of the manufacturing process. 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.

  • Ensures all documentation pertinent to each face of the manufacturing process is reviewed at the line clearance phases. processed i.e. correct stock solution, labels, data sheets, documents and all packaging material i.e. bottles, tips, caps, bags, platforms, boxes etc.
  • Performs a thorough review of manufacturing documentation to ensure compliance to department process. Reviews process documentation to ensure the revision being used is reflective of what is found in Document Changes and that all information is accurate i.e. Part Number,
  • Lot Number, Expiration Date and is signed as appropriate by the technician performing the task.
  • Utilizes the Shelf Life List in Document Changes during Line Clearance activities to ensure the expiry date given is reflective of what is called for in the list.
  • Reviews product packaging labels to ensure information is accurate to the product being assembled i.e. Part Number, Lot Number, Expiration Date, Storage conditions, Product Description, Product Class (IVD, RUO, ASR) and ensures all pertinent symbols are present i.e.
  • hourglass, thermometer etc.
  • Utilizes the raw material Master Lists to ensure the material being used is approved for the product being manufactured.
  • Create and review Certificate of analysis and Certificate of Conformity as necessary for Finished goods.
  • Other duties as assigned by Management.

Competencies

  • High School Diploma or GED required with a minimum of two (2) years of experience in a GMP regulated facility.
  • High-level of reading comprehension.
  • Must be able to write clear, understandable documentation with effective presentation of information.
  • Demonstrates independent judgment within broadly defined policies and practices in resolving problems and making recommendations.
  • Basic computer literacy required.
  • Working knowledge of FDA/GMP/ISO standards.
  • Ability to work in a high-pressured deadline-oriented environment.
  • Understanding of basic math principles required.

Compensation Range

  • $25.00 - $32.00 hourly

Expected Hours of Work

  • 7:00 a.m. to 4:00 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.

More Information on Biocare Medical, LLC
Biocare Medical, LLC operates in the Biotech industry. The company is located in Pacheco, CA. Biocare Medical, LLC was founded in 1997. It has 236 total employees. To see all 9 open jobs at Biocare Medical, LLC, click here.
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