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Quality Systems Specialist

Company: Lykan Bioscience
Location: Hopkinton
Posted on: August 6, 2022

Job Description:

WHO WE ARELykan Bioscience is a fast-growing and innovative contract development and manufacturing organization (CDMO) focused on cell-based therapies. Cell therapy, one of the most transformative innovations in modern biotechnology, holds enormous potential for treating patients suffering from a variety of diseases. We are on a mission to improve patients' lives by innovating and delivering advanced cell-based therapies.
OUR PASSIONWorking at Lykan is not just a job, it's an opportunity to work with a great team with diversified backgrounds and top-tier innovative biotechnology companies to contribute to the development and manufacture of revolutionary, life-saving treatments. Our team's passion for patients uniquely defines us. It's not about what we do; it's about why we do what we do.
THE LYKAN WAYHere at Lykan, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Innovation, Excellence, Teamwork, Integrity, Trust, and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success, at Lykan we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE The Quality Systems Specialist is a position responsible for supporting the development, implementation, and on-going management and implementation of the Quality Management Systems including Deviation, CAPA, Change Control, Quality Management Review, as well as participate in electronic system implementation and integration into plant operations. The ideal candidate is a self starter with experience in a start up environment, understanding of GMP and other experience with and/or supporting Cell Therapy and/or GMP Environment.

  • Support execution and continuous improvement for the Quality Management Systems including but not limited to Deviation, CAPA, Change Control
  • Computer system evaluation, validation, implementation and integration into plant operations with the goal of a paperless plant
  • Monitor implementation of systems and assist in execution of quality systems, ensuring compliance to SOPs and identifying areas for improvement
  • Quality reviewer / approver for Quality Systems, including Deviation, CAPA, Change Control
  • Support health authority inspections and client audits
  • Support reporting of KPIs as part of Quality Management Review
  • Able to cross train with QA Operations for coverage as needed for various procedures
    • 1-3+ years relevant Quality Assurance experience in a pharma/biotech company, working within a Quality System, regulated GMP environment and/or computer-related system evaluation / validation. Cell therapy experience a plus.
    • Prior experience with implementing and/or executing quality systems, serving as Quality reviewer/approver, and/or continuous improvement initiatives focused on quality systems
    • Ability to partner cross functionally and integrate feedback with quality systems
    • Ability to work independently to meet objectives and timelines
    • Has an awareness of cGMP and ICH regulations/ guidelines
    • Minimum GED or High School Diploma, Associates or Bachelors degree preferred
    • *This is a full time position, Monday through Friday. Occasional evening and weekend support may be required to support Quality Operations during manufacturing shift operations or implementation of a new system.
      OUR COMMITMENTAll Lykanians embrace the principles of the Lykan Bio culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.Lykan is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Keywords: Lykan Bioscience, Worcester , Quality Systems Specialist, Other , Hopkinton, Massachusetts

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