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Danaher Corporation Quality Assurance Analyst in Shrewsbury, Massachusetts

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.

What you’ll do

This individual is responsible for coordinating activities related to the Material Review Board (MRB) Process such as issuing and processing Non-Conforming Material Reports (NCMRs). This includes the physical movement of material in and out of the MRB holding areas as well as the related inventory transactions.

  • Initiate NCMR Forms when non-conforming or suspect product is identified at incoming inspection, manufacturing and the warehouse.

  • Physically moving components, bulk raw materials, Finished Goods into MRB areas

  • Proper labeling of MRB material that is stored in designated MRB areas.

  • Performing Oracle inventory move transactions of material in and out of MRB locations

  • Assisting with containment activities to ensure all nonconforming or suspect material is found and place in a MRB location.

  • Attending and supporting action items related to weekly MRB meetings or as directed by the QA Engineers running the MRB meeting.

  • Documenting NCMR investigation results on NCMR forms and tracking open NCRMs via spread sheet.

  • Performing inventory cycle counts of NCMR materials located in the MRB locations.

  • Assist with the implementation of rework, UAI, scrap and RTV dispositions.

  • Verifying through objective evidence MRB dispositions (rework, return to vender, use as is, or scrap) have been properly completed per the NCMR Work Instructions.

  • Participates in special projects as they arise, including efficiency projects, streamlining of documentation, cross-site projects

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities

  • Maintaining monthly metrics for MRB, Nonconformance, CAPA and other quality metrics as applicable

  • This job description is not all inclusive and is intended to capture most of the job functions. Special projects and other tasks may be required by management.

Who you are

  • Bachelor’s degree or equivalent experience is required, preferably in business, engineering, or other technical field.

  • Minimum of 3 years related experience in a manufacturing environment.

  • Experience in a regulated manufacturing environment (FDA CFR 21 820 and ISO 13485) is preferred. (cGMP and GDP concepts)

  • Experience with MS Office word processing and Excel Spreadsheets

  • Experience with Oracle or similar Inventory Management databases is preferred.

  • Strong analytical skills and attention to details.

  • Strong oral and written communication skills.

    When you join us, you’ll also be joining Danaher’s global organization, where 68,000 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 (https://www.danaher.com/how-we-work/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.

    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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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