Quality Assurance Specialist
1 week ago
Job Title: Quality Assurance Specialist II
About the Role:We are seeking a highly skilled Quality Assurance Specialist to support our organization's commitment to delivering high-quality products and services. As a key member of our team, you will play a critical role in ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:- Change Control Management: Manage the change request process, ensure timely review, and arrange change control meetings to review changes related to design, manufacturing processes, product design, and documentation.
- CAPA Process Support: Collaborate with CAPA owners to ensure root cause analysis, action plan development, execution, and effectiveness checks, and timely closure.
- Management Review Meetings: Prepare and organize materials for periodic management review meetings in accordance with ISO 13485:2016.
- Audit Support: Provide active support during internal audits and external audits/inspections, including front room and war room roles.
- QMS Process Maintenance: Support the maintenance and improvement of QMS processes, including Document Control, Change Control, CAPA, Internal Audit, and Management Review.
To be successful in this role, you will need:
- Bachelor's degree or equivalent in a related life science/technical discipline or equivalent preferred.
- ISO 13485:2016 Lead Auditor certified preferred.
- At least 2+ years' experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Experience with QMS databases (i.e., Veeva, SAP).
- Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
- Strong communication and coordination skills across cross-functional and global teams.
- Decision-making, time management, organization, and computer skills.
- Working knowledge of In-Vitro Diagnostic Device/Medical Device/Biotech manufacturing processes.
We offer a comprehensive benefits package that includes:
- Comprehensive medical plans and insurance.
- Flexible benefits.
- Wellness programs.
- Extensive learning and development opportunities.
We are a global leader in developing, manufacturing, and marketing high-quality research and clinical diagnostic products. Our mission is to help people everywhere live longer, healthier lives.
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