Senior Quality Assurance Specialist
1 week ago
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Iovance Biotherapeutics Inc. This role will be responsible for ensuring the quality and regulatory compliance of our commercial and clinical products.
Key Responsibilities:- Represent Iovance QA by working on-site at contract service providers.
- Support manufacturing, testing, and release activities.
- Establish direct lines of communication with CMO QA functions.
- Review and approve master/executed batch records.
- Release/reject clinical lots and issue release certificates.
- Develop and review Standard Operating Procedures (SOPs) for GMP compliance.
- Support quality management review metrics and regulatory inspection activities.
- BA/BS degree in life sciences discipline or equivalent.
- 5+ years of biopharmaceutical industry experience.
- Direct experience with review of clinical manufacturing documentation and release of clinical product.
- Strong working knowledge of GMPs and Health Authority standards.
- Ability to follow through on activities to ensure projects are completed as planned.
This position will work in both an office and a manufacturing lab setting. Must be able to work in a cleanroom with biohazards, human blood components, and chemicals.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. We are an equal-opportunity employer and welcome applications from diverse candidates.
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