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Quality Control Associate
2 months ago
Company Overview
At Northreach, we are dedicated to pioneering innovative and transformative therapies aimed at improving patient outcomes. Our mission is to establish a leading global biopharmaceutical organization focused on delivering significant advancements in the treatment of autoimmune and inflammatory conditions, as well as enhancing organ transplantation success through our specialized engineered Tregs.
Position Summary
We are in search of a skilled and enthusiastic professional with a background in Quality Control within the cell therapy domain and experience in GMP environments.
Key Responsibilities
The Quality Control Associate will:
- Ensure adherence to Good Documentation Practices while recording data and preparing reports.
- Assist in the selection and procurement of suitable QC laboratory equipment and materials.
- Support the transfer of QC testing methodologies from the Analytical Development team and engage in equipment qualification processes.
- Contribute to the creation of reports, forms, SOPs, and regulatory documentation as necessary, and aid in QC stability initiatives.
- Help manage stock and maintain the QC laboratories, including the cleaning and upkeep of instruments.
Qualifications
The ideal candidate will possess:
- A minimum of one year of experience in a GMP Quality Control laboratory.
- Proficiency in aseptic techniques, sterility testing, cell counting, flow cytometry, PCR, mammalian cell culture, and potency testing.
- Experience in supporting the qualification of assays in accordance with ICH guidelines for batch release and stability testing of cell-based therapies.
Diversity and Inclusion
Northreach is an equal opportunity employer. We are committed to fostering a diverse, equitable, and inclusive workplace and do not discriminate against any employee or applicant based on race, color, religion, sex, national origin, disability, or age. We prioritize partnerships with organizations that share our commitment to diversity, equity, and inclusion in their hiring practices.