Bio-Rad is seeking a Quality Systems Specialist to support the Northern California Quality Assurance team. This position will support the Northern California Quality Systems document control functional team.

Responsibilities

• Process obsolete document requests and verify document obsolescence justifications.


• Promptly evaluate documents change requests and assign appropriate reviewers for further review.


• Manage the review, formatting, uploading and release of controlled documents in electronic quality management system (eQMS).


• Verify and assess documents with special Quality Assurance instructions to make sure that requested instructions are performed prior to release such as document obsolescence and release date consideration


• Correctly perform due date extension, reassignment and rerouting of designated documents for timely review and approval.


• Issue controlled documents for training, follow up as necessary.


• Communicate document release, obsolete, and pending documents requiring training prior to release and provide assistance in explaining current document phase when needed.

Qualifications

• Associate degree or equivalent in Biology, Chemistry, or related field.


• 2+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.


• Basic understanding of GMP/GDP/QSR/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).


• Detail-oriented, excellent organization and project management skills and ability to multitask.


• Decision making, time management, organization, communication, leadership, and computer skills.


• Proficient in Microsoft Office, Visio and Excel


• eQMS (EtQ) and SAP experience is a plus


• Effective Communicator

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 leaderprovidinga broad array of clinicaldiagnostics andlifescienceresearchproducts. 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.

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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.