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Quality Assurance Specialist

Company: Danaher
Location: West Jordan
Posted on: November 12, 2021

Job Description:

Be part of something altogether life-changing! Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term. Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. Cytiva and Intermountain Life Sciences are excited to be working together to expand the ILS operation. From January 1, 2022 all ILS associates will receive an upgraded benefits package to include a 401(k) with company contributions, annual production bonuses, referral bonuses, additional insurance options, and more. What you'll do * Assist in the maintenance of company's quality program documentation to ensure conformity to internal and external quality standards. (ISO and GMP) * Initiates and maintains vendor and customer qualifications * Releases raw materials and finished goods * Quarantines non-conforming material for review by the MRB * Meets with vendors, customers, quality representatives, and company personnel to discuss and resolve quality problems as required. * Prepares for and supports Quality and Operations departments during all quality audits * Assists Quality department personnel to prepare all necessary reports as required by customers, QA department needs, and staff personnel * Monitors budgetary control issues * Coordinate with multiple departments to ensure accurate and timely documentation * Maintains internal audit schedule to ensure compliance of all departments with quality procedures * Perform external audits as needed with supplier and distributers * Maintain label program, monthly review records, and temperature graphs * Perform validation protocols and final reports * Assist as needed with lab testing and research * Manage product label and product specifications as well as new product requests Who you are * Bachelor's degree from an accredited institution (Experience may be considered in lieu of a degree in unique circumstances). * Demonstrated understanding or aptitude to understand regulatory requirements including FDA CFR 21 820 and ISO 13485. * Demonstrated proficiency in word processing, spreadsheet, and presentation software. * Strong interpersonal communication skills with the ability to effectively communicate and work interdepartmentally. * Ability to accomplish goals and work with minimal supervision. * Demonstrated understanding or aptitude to understand continuous quality/process improvement tools (5S, SPC, DMIAC, root cause analysis tools, etc.). * Positive, team-player that consistently goes above and beyond. * Maintains a positive attitude, is self-motivated, and works well independently and as part of a team. * Three years of relevant work experience. * Quality Assurance experience in a regulated industry strongly preferred. When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll 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 is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible. If you've ever wondered what's within you, there's no better time to find out! Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail applyassistance@danaher.com to request accommodation. When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll 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 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. The EEO posters are available here. 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 applyassistance@danaher.com to request accommodation. If you've ever wondered what's within you, there's no better time to find out.

Keywords: Danaher, West Jordan , Quality Assurance Specialist, Other , West Jordan, Utah

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