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Quality Assurance Specialist CMC (Deviations & CAPA)

Company: Adaptimmune
Location: Philadelphia
Posted on: May 5, 2021

Job Description:

Primary ResponsibilityThe CMC Quality Assurance Specialist provides support and guidance for all products manufactured at Adaptimmune, LLC.-- Following Adaptimmune, LLC Quality Policies and Procedures, the CMC Quality Assurance Specialist participates in the activities related to product release, Quality investigations, auditing, customer complaints, CAPA, raw material, in-process and final product release.Key ResponsibilitiesReview and Approve Incident Reports, Deviations, ensuring timely closure and adequate investigations have been performed to drill down to root cause.-- Properly interpret and apply current regulatory requirements during these reviews.-- Perform timely notification to QPs on newly issued deviations associated with European T-cell lotsPerform deviation trending and investigation Write-Up with thorough Root Cause determinationsAssist in driving CAPA closure to meet 90-day turn-around-time deliverable. Collaborate with Manufacturing, Quality Control and MS&T on determining appropriate CAPAs for root cause mitigation as well as determining appropriate follow up Effectiveness ChecksRun weekly (2x week) deviation review board meetings to assess criticality of deviations and identify corrective and preventative actionsAssist in keeping up-to-date Deviation and CAPA Key Performance Indicator metrics to ensure data accuracy for Quality Site Council Updates.-- Qualifications & ExperienceRequiredRequires BS/BA in scientific discipline or related field with minimum 3 years of relevant work experience in biologics, advanced cell and gene therapy or related industryDirect experience with review and approval of deviations and CAPA recordsExtensive knowledge of GMP, ICH and FDA/EMA regulationsExcellent technical writerPrevious Gowning experience in aseptic environmentDesirableKnowledge of MasterControl and MODA-EMKnowledge of aseptic processing and aseptic gowningKnowledge of cell & gene therapy production processesSKILLS & COMPETENCIESRequiredExcellent written and verbal skillsAbility to work and communicate internally and externallyRoot Cause AnalysisDetermining and Implementing Corrective and Preventative ActionsDesirableAble to manage multiple prioritiesExcellent problem-solving skillsAble to exercise judgement to determine appropriate corrective actionsAt Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.Powered by JazzHR

Keywords: Adaptimmune, Philadelphia , Quality Assurance Specialist CMC (Deviations & CAPA), Other , Philadelphia, Pennsylvania

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