Quality Assurance Specialist

3 weeks ago

London, Greater London, United Kingdom Northreach Full time
Position Overview

Northreach is collaborating with a partner dedicated to providing groundbreaking, transformative therapies for patients. Our mission is to establish a prominent global biopharmaceutical entity focused on delivering innovative and valuable treatments for various autoimmune and inflammatory conditions, as well as facilitating organ transplantation through engineered Tregs.

ROLE SUMMARY - Quality Assurance Specialist

We are in search of a skilled and driven professional with a background in Quality Assurance within the cell therapy domain and GMP environments. The ideal candidate should possess a solid grasp of the regulatory frameworks governing Quality Assurance in Phase 1/2 clinical production, including essential GMP standards such as Good Documentation Practices.

KEY RESPONSIBILITIES:

  • Facilitate Clinical Trial production by conducting Quality Control assessments across diverse areas, including microbiology, mammalian cell culture, flow cytometry, qPCR, and potency evaluations.
  • Assist in the validation and qualification of testing methodologies, processes, and equipment to confirm their appropriateness for Clinical Trial production support.
  • Adhere to Good Documentation Practices in data recording and report generation.
  • Contribute to the selection and procurement of suitable Quality Control laboratory instruments and materials.
  • Support the transfer of Quality Control testing methodologies from the Analytical Development Team and engage in equipment qualification tasks.
  • Participate in the creation of reports, forms, SOPs, and regulatory documentation as necessary, and assist in Quality Control stability initiatives.
  • Help manage inventory and maintain the Quality Control Laboratories, including the cleaning and upkeep of instruments.

QUALIFICATIONS AND EXPERIENCE:

  • Familiarity with critical process parameters (CPP), critical quality attributes (CQA), and comparability related to manufacturing processes.
  • Knowledge of pharmaceutical GMP regulations.
  • Exceptional attention to detail and the ability to meticulously follow Standard Operating Procedures (SOPs).
  • A minimum of one year of experience in a GMP Quality Control laboratory.
  • Proficiency in various biopharmaceutical and cell-based techniques, including but not limited to: Aseptic techniques, Sterility assessments, Cell Counting, Flow cytometry, PCR, Mammalian cell culture, and Potency evaluations.
  • Experience in supporting the qualification of assays (ICH) for batch release and stability testing of cell-based therapies.

Northreach is an equal opportunity employer, committed to fostering diversity, equity, and inclusion in the workplace. We do not discriminate against any employee or applicant based on race, color, religion, sex, national origin, disability, or age. We strive to create a welcoming and inclusive environment for all employees.

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