Quality Specialist

Organization
Illumina, Inc
Job Location
800 Saginaw Drive
Redwood City, CA 94063
Salary
market salary DOE, bonus potential, equity
Benefits

PTO, ESPP, 401k, medical/dental/vision, etc.

Job Description

Basic Function and Scope of Position
 
This position supports quality assurance activities related to quality system compliance and continuous improvement. The ideal candidate will have a Quality Assurance background in an in vitro diagnostic or molecular reagent company and/or a product development background in molecular biology products or molecular diagnostic products company utilizing nucleic acid technology (e.g. PCR, sequencing, etc) is a plus.
 
 
All About You
 
Responsibilities: 

  • Manage or support the training program as well as suggest and implement improvements to existing process.
  • Manage or support the document control program as well as suggest and implement improvements to existing process.
  • May assist in the investigation and resolution of nonconforming events and CAPA projects.
  • Support the batch record review process this may include the review, investigation and resolution of issues with batch records.
  • Perform trending analysis (Quality Metrics) on an as needed basis, including using statistical process control methods.
  • Work with management to improve quality system policies and procedures.
  • Assist in internal and external audits.
  • Write and/or review documents.
  •  Perform other duties as assigned         
Requirements
  • 5-8  years of direct work experience in QA, including all aspects of device/diagnostic quality systems
  • Experience with ISO 13485 and 21 CFR 820
  • Excellent problem solving and analytical skills.
  • Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
  • An understanding of GDP, FDA Quality System Regulations, CLIA and/or ISO Standards (ISO 13485 and ISO 14971) is a plus.
  • Quality engineering experience is a plus.

 
Education:
 

  • B.S. Degree in Molecular Biology or related field plus 4 years of industry experience; in vitro diagnostic or molecular reagent quality assurance preferred or
  • A.S./High School Diploma plus 8 years of industry experience; in vitro diagnostic or molecular reagent quality assurance preferred.
How to Apply

Apply on-line for job ID number 2787BR via the careers page of the company's web site:

http://www.illumina.com/company/careers/search-jobs.html

 

 

 

About Our Organization

Headquartered in San Diego, California, Illumina (NASDAQ: ILMN), is a leading developer, manufacturer, and marketer of next generation life science tools and integrated systems for large-scale analysis of genetic variation and biological function. These systems are enabling studies that were not even imaginable just a few years ago, and moving us closer to the realization of personalized medicine. With the innovative advances in our sequencing technologies, we are rapidly impacting the clinical market in areas such as reproductive health and oncology. The expanding Illumina oncology portfolio of next- generation sequencing NGS and microarray technologies is revolutionizing cancer genomics research. Our customers include a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the globe.
 
lllumina has experienced phenomenal growth from $10 million in revenues in 2002 to over $1.4 billion in 2013. Forbes named Illumina #1 on the 2009 list of 25 Fastest-Growing Technology Companies in the United States, the second time over a three year period that Forbes ranked Illumina #1 on its list of rapidly growing technology companies. Illumina was also named #1 smartest company in the world as part of MIT’s 2014 Technology Review.  As of August 2014, the company had a $24 billion market capitalization. 

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