As a six month temporary and part of the Quality Assurance team, this position will support quality system functions including Risk Management and Change Control. This position will work with cross-functional teams to complete Risk Management documentation and change control packages.
Post market surveillance: Review product information and generate plans. Work with cross functional teams to generate, review and summarize applicable QMS data (change control, non conformities, CAPA). Draft post market surveillance reports following existing template.
Change control management: Complete minor document revisions, initiate change control packages, track progress and complete implementation activities.
Labeling: Conduct minor consistent revisions, proofing and change control activities.
Bachelor's degree or equivalent preferred 2+ years experience in a regulated manufacturing industry or
equivalent combination of education and experience Detail-oriented and ability to multitask Report writing
skills Basic understanding of GMP and quality systems standards desirable (13485 and IVDR) Proficient on Microsoft 365 programs SAP knowledge a plus.
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.
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.