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QA Specialist IV

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POST DATE 8/31/2016
END DATE 12/7/2016

Bio-Rad Laboratories Hercules, CA

Hercules, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description

What you ll be doing:

* Provide QA Support to manufacturing operations in the areas of change control, validation, nonconformance and CAPA

* Support external, internal and supplier audits

* Perform training on Quality System regulations

* Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485

* Certified Lead Auditor with medical device focus a plus

* Full working knowledge of investigational techniques and risk analysis

* Serve as QA team member on product development projects to ensure compliance with design controls

* Advise, evaluate and approve protocols, reports, and SOPs to ensure compliance with internal requirements as well as to standards/regulations for worldwide distribution

What you need for this role:

* BS degree in a science related field

* 7+ years working in a FDA regulated industry, preferably medical device/IVD. Successful track record of collaboration with manufacturing and other cross-functional departments

* Prior manufacturing or analytical experience a plus

* Strong interpersonal skills with the ability to build cross functional relationships

* Must be self-motivated with the ability to work as a team player and/or independently

* Advanced problem solving and communication skills.

* Knowledge of chromatography, immunoassays and manufacturing operations a plus

What s in it for you:

* Competitive pay and great benefits including medical, dental, vision, 401k and more

* Opportunities for growth and training

* Stability of a profitable 60+ year old company

* Great work environment

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age Employer

To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.


Bio-Rad Laboratories continues to play a leading role in the advancement of scientific discovery by providing a broad range of innovative products to the life science research and clinical diagnostic markets. Founded in 1952, Bio-Rad serves research and industry customers around the world through its global network of operations.

Company Size:
5,001-10,000 Employees
Bio Technology
1000 Alfred Nobel Drive
Hercules, CA 94547

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