QA Supervisor This company is a pioneer in the cGMP production sector and is committed to developing gene therapy. Their goal is to create novel, secure, and efficient long-term treatments for illnesses by utilizing their expertise, resources, technology, and knowledge in the fields of translational and regulatory science. As they work to make a difference with every product and instill hope in the hearts of every patient and their family, there is no condition too uncommon or difficulty too great. The main idea of this biotech company is the full-service production of Adeno Associated Viruses (AAV). Every year, they collaborate with more than 100 clients to produce AAV at levels of development, toxicological, clinical, and.
Qualifications: Working knowledge of team function within the organizationExcellent detailed knowledge of cGMP, GLP, FDA guidelinesExcellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities changeMust be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reportingAbility to work independently as well as collaboratively in a diverse and inclusive work environmentMust possess a client-focused mindset in daily tasksResponsibilities: The QA Operations Supervisor role is responsible for supporting internal Quality Assurance functions focused on GMP manufacturing operations and associated Quality systems, including change controls and internal process verificationThe supervisor will work collaboratively with the training team to ensure manufacturing colleagues are operating in compliance with Quality systemsExecute Quality systems to support CDMO manufacturing and lot release, GxP auditing, and trainingProvides quality support for external and internal AAV and Plasmid manufacturing and clinical product distributionReview and audit complex documents: batch records, GMP protocols, and process and method validationsFully support the Product Disposition of client AAV and Plasmid lots for releaseReview and approve master and executed batch recordsObserve manufacturing activities to support the implementation of best practices and improvementsAdminister, review, follow-up, and approve internal/external Deviations, Change Records, and Corrective and Preventive Actions (CAPAs)Manage the DMS by authoring, reviewing, and approving Policies, SOPs, and WINs as neededCommunicate quality metrics, client production tracking and metrics, and quality improvement initiatives to senior leadershipProvide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trendsAct as QA SME during client and regulatory auditsSchedule QA-on-the-floor responsibilities for the QA Operations team in support of manufacturing activitiesEnsures that documentation is maintained in accordance with internal procedures and regulatory requirementsSupports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departmentsExercise discretion, judgment, and personal responsibilityBenefits: The opportunity to work alongside experts who have over 10 years in the gene therapy fieldCompetitive compensationEligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid160 hours of Paid Time Off annually11 Company Paid Holidays plus 2 floating holidays annuallyCompany Paid Life Insurance401(k) MatchCompany Paid short and long-term disability4 weeks of Paid Parental Leave for birth and adoptionAdoption AssistanceTuition Reimbursement and Student Loan Repayment AssistanceCompany Paid LinkedIn Learning accessEmployee Assistance ProgramsFlexible work options (role specific)
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