16 days old

Quality Product Release Specialist: 2nd Shift: Sun- Wed 2:00pm- 12:30am

Danaher
Westborough, MA 01581

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

What you'll do

The Product Release Specialist is responsible for review and approval of assembly, testing, inspection and factory acceptance testing (when applicable) documentation of finished product to confirm quality conformance to specifications and quality deliverables. SHIFT SCHEDULE 2nd Shift: Sunday- Wednesday 2:00pm- 12:30am

  • Responsible for quality release of finished good products to packaging for shipment.
  • Analyze and review manufacturing and test data in written or electronic form to verify accuracy and completeness necessary for the final release. This also includes subcontractor records when product is processed by a 3rd party (i.e. sterilizer records).
  • Create tasks in electronic batch record data collection system to resolve product and process discrepancies.
  • Issue Certificate of Quality for final product release when all release requirements have been verified and met.
  • Provide consultation and guidance to other groups concerning documentation completeness, accuracy as well as related manufacturing quality management systems and processes.
  • Collaborate timely with Cross functional teams to aid effective investigations & problems solving
  • Interface with manufacturing to coordinate product release activities to best support production build and shipping schedules.
  • Provide input for deviations and product concessions. Support Quality Assurance Engineers with deviation, investigation, and rework documentation review.
  • Continually identify, recommend and implement process improvements with a lean and quality focus.
  • Comply with EHS regulations & policies.
  • Responding to routine quality related queries from other departments.
  • Monitoring and aiding the implementation of continuous improvements and process changes to ensure these are implemented in compliance with GMP.


    Who you are

    • High School Diploma required (Associates or applicable Certification preferred)
    • 1-year experience in a medical device or pharmaceutical industry.
    • 1-year experience with CA/PA systems, including complaint handling.
    • Thorough familiarity with cGMPs of sterile product manufacture.
    • Knowledge of relevant Electronic Management Systems transactions and familiarity with Excel / Word packages.


      Desired Characteristics

      • Bachelor€™s degree
      • Demonstrated knowledge of Quality Management System Tools and continuous improvement methodologies.
      • Demonstrated collaboration, negotiation & conflict resolution skills.
      • Effective communication skills (written and oral).
      • Ability to multi-task & handle tasks with competing priorities effectively.
      • Technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).
      • Experience with generating, tracking and interpreting quality metrics.
      • Demonstrate support to a positive quality culture


        Who we are

        Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you€™ll feel right at home here. If you€™re flexible, curious and relentless, you€™ll belong. If you are excited about a global culture, this can be the place to further your career.

        Want to know more? Take a look at our Instagram, Twitter and LinkedIn pages!

        Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

        As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher€™s unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life€™s Potential.

        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 €œEEO is the Law€ poster is available here.","industry":"Biotechnology

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Posted: 2020-05-21 Expires: 2020-06-20

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Quality Product Release Specialist: 2nd Shift: Sun- Wed 2:00pm- 12:30am

Danaher
Westborough, MA 01581

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