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Quality Assurance Supervisor
Cepheid
2021-12-04 00:46:53
Sunnyvale,
California,
United States
Job type: fulltime
Job industry: Other
Job description
2 Shifts Available
Shift: Tue-Sat (2pm - 10:30 pm)
Shift: Mon-Fri 6 am -2:30 pm
PRIMARY RESPONSIBILITIES:
- Responsible for prioritization of daily QA activities to ensure batch record and document releases are met .
- Review batch records and documents, for completeness and compliance with QSR and ISO requirements to support release of raw materials, work in progress and final products. This includes components, consumables, reagents, components, and instrumentation-related products.
- Train and supervise QA personnel to support QA release activities .
- Address deficiencies and ensure completion of follow-up actions, specifically those that target process fixes to maintain consistent resolution to all batch review issues according to GMP standards.
- Positive interaction with internal Associates to resolve issues quickly and effectively.
- Manage and support Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
MINIMUM REQUIREMENTS:
Education or Experience:
- Bachelo r s degree i n scientific , quality system , or related discipline, wit h minimum 8 years of quality related experienc e i n a regulated manufacturing environment or Master degree i n scientific , quality system , or related discipline, wit h minimum 4 years of quality related experienc e i n a regulated manufacturing environment .
Knowledge and skills:
- Effective problem solving, analytical and organizational skills
- Solid understanding of technical processes, DHR requirements, and inspection and testing processes.
- Advanced experience with risk management and design control principles
PREFERRED QUALIFICATIONS:
- Experience in DNA diagnostics or other medical devices
- Certified Quality Engineer, Certified Quality Auditor or similar certification.
- Knowledge of quality and manufacturing processes and methods
PHYSICAL DEMANDS
- Ability to work in an office environment
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
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When you join us, youll also be joining Danahers global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, youll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID19 as a condition of employment, subject to reasonable accommodation as required by law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
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