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Quality Systems Specialist - Temporary

  • 2025-36506
  • Irvine, California, United States
  • Quality & Regulatory
  • Hybrid

This position will support the compilation and maintenance of IVDR technical files, review IVDR and other registration labeling change requests and various quality tasks to support the QMS overall.

 

How You'll Make An Impact:

  • Review, approve, and process labeling and FOC change requests
  • Compile, create, review, and update quality related technical file documentations (i.e. DMR updates, compile finished product testing documents, etc)
  • Various quality tasks such as LS FOC creation, non labeling related change requests, etc

What You Bring:

  • Education: Bachelors degree preferred or high school diploma/equivalent with 2 to 3+ years of work experience
  • Work Experience: 2+ years experience in Quality, Documentation Control, Change Control process, GMP
  • Basic understanding of GMP and quality system standards
  • Proficient in Microsoft office (word, excel, etc)
  • Detailed oriented with the ability to multi-task

Compensation: The estimated hourly range for this position is $32 to $36 per hour at the time of posting.  Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.  As a temporary associate, your employment will be managed directly through our approved agency provider.​

 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

 

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

 

Agency Non-Solicitation:  Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it.

 

 

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