Quality Assurance Specialist, Cell
1 month ago
Piper Life Sciences is actively seeking a Quality Assurance Specialist to join a cell &gene therapy organization developing innovative AAV platform products for challenging diseases. The Quality Assurance Specialist will be responsible for the review and approval of data in a GMP environment. This is a Monday - Friday, traditional hours role that is hybrid in Durham, North Carolina.
Responsibilities for the Quality Assurance Specialist
Responsible for compliance review of pharmaceutical manufacturing data throughout the facility.Collaborate with cross functional groups like manufacturing, process development, and other departments liable for GMP activities, to support resolution of deviations and other compliance discrepancies.Support CAPAs, Change Controls, Deviations, Out of Specifications and Laboratory investigation records.Support other quality functions like incoming inspection, material revision, implementation projects, as assignedQualifications for the Quality Assurance Specialist:
BS in an applicable field with 3 - 7 years of QA experience in a GMP environmentExperience in QA Review and approval of quality systems records like Deviations, CAPA, Change Controls, and LIRsKnowledge of USP, EU, JP, and/or GMP knowledge 3+ years of experience in a pharmaceutical organization, ideally in a cell and gene therapy manufacturing environmentCompensation for the Quality Assurance Specialist:
Salary Range: $45 - $65/hr., based on years of applicable industry experience Comprehensive Benefits: Medical, Dental, Vision, 401k, PTOKeywords: quality assurance, QA, quality control, QC, specialist, laboratory, laboratory data, analytical, analytical development, manufacturing, batch records, cGMP, GMP, compliance, data review, support, laboratory, biologics, small molecule, resolution, deviation, raw materials, improvement, training, mentoring, essential, biopharma
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