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Danaher Corporation Quality Systems Specialist in Bothell, Washington

Description

Cepheid, Bothell, WA. is seeking a Quality Systems Specialist responsible for ensuring chemical and oligonucleotide reagent product quality by employing best practices to review for compliance to applicable procedures, Cepheid Corporate Quality Polices and Medical Device regulations (QSR) and ISO standards. The Quality Systems Specialist’s functions include material and product review and release and records management.

ESSENTIAL JOB RESPONSIBILITIES:

  • Release raw materials.

  • Review production batch records, QC test results and release product.

  • Records management; includes filing, logging, tracking, laboratory notebook issuance and other duties associated with record storage and archiving.

  • Review records and documents for completeness and compliance with company policies and procedures.

  • Audit documentation such as buffer manufacturing logbooks, equipment logbooks, laboratory notebooks and stability data.

  • Support validation activities for equipment and facilities. This includes review of protocol execution raw data and report data.

  • Partner with company associates to strengthen compliance. Facilitate and assist with initiatives for continuous improvement.

TRAINING RESPONSIBILITIES: (REQUIRED)

  • Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience (in years):

  • High school degree (or equivalent experience) with 2-4 years of related work experience OR

  • Associate degree in scientific discipline with 1-2 years of work experience in a regulated manufacturing environment

Knowledge and skills:

  • Exceptionally strong organization, accuracy, and attention to detail skills required.

  • Strong documentation review skills.

  • Excellent verbal and written communication skills in-group and one-on-one settings.

  • Ability to partner well in a diverse environment.

  • Computer skills: Microsoft Office with strong Excel and Access skills.

Preferred experience, knowledge and skills:

  • Medical device manufacturing or quality experience preferred.

  • Bachelor’s degree in scientific discipline.

  • Chemistry, biochemistry or DNA diagnostics experience preferred.

  • Experience with qualified equipment preferred.

  • Experience with electronic document management, quality management, training management and/or equipment management systems preferred.

Physical requirements/abilities:

  • Ability to work in an office environment.

  • Ability to lift boxes up to 30 lbs.

  • Ability to be in laboratory environments.

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.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

Operating Company: Cepheid

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