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Quality Assurance Specialist - IT

Quality Assurance Specialist - IT

  • 2021-26354
  • Hercules, California, United States

A Quality Assurance Specialist in Information Technology participates in compliance initiatives supporting company policies and Regulatory requirements related to product and internal IT controls for 21 CFR Part 820 & Part 11, Annex 11, and other applicable health care industry standards/best practices. IT QA also assists our IT unit to integrate best practice concepts into our processes to increase efficiency and meet compliance requirements and assure our customers receive only the highest quality services.

Responsibilities

  • Support Application teams to facilitate the SDLC process for new Applications & Systems including:
    • Participate in Risk Impact Analysis for Infrastructure and Application installations and upgrades.
    • Provide guidance on Quality System Regulations to define applicable requirements.
    • Review project deliverables to assure quality system standards and internal procedural requirements are met.
    • Review and approve test instructions and records in support of validation activities.

Qualifications

  • Bachelor's degree or equivalent in a related life science/technical discipline.
  • 6+ years’ experience in a regulated industry, or equivalent combination of education and experience.
  • Understanding of international standards and regulations (e.g. ISO 13485,  21CFR Past 11, GxP)  as they apply to computer systems used in the quality system and for the development and manufacture of Bio-Rad products.
  • Problem solving, time management, organization, communication, leadership and computer skills.
  • Able to write clear and concise summaries of complex technical topics.
  • Strong interpersonal communication and presentation skills.

 

Vaccination Requirement:

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad recently announced a new mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. Bio-Rad will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.

 

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 8,000 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

 

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.

 

 

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