Remote QA Person Inplant

Our client a, patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases seeking a QA Person In plant to join their growing team.Do you have the skills to fill this role Read the complete details below, and make your application today.Responsibilities:Perform batch record review of investigational products manufactured at CMO partners.Perform QA/client review for internal and/or CMO Quality System records, manufacturing documents, analytical methods, and qualification/validation documentation.On-site oversight of CMO operations as needed.Ensure all necessary documents/forms/records are authorized to facilitate movement of cell product to clinical sitesSupport Manufacturing to collect and monitor key performance indicators of CMO and contract/external laboratories.Review, maintain, and execute against Quality Agreements with the Supplier/CMO network.Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.Skills:8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years' experience in the field of cell therapies preferred.Expertise with cGMP manufacturing as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPsAbility to operate in a Controlled/Classified Environment, including ability to successfully maintain aseptic technique and complete cleanroom gowning qualification requirements.Demonstrated ability to manage multiple complex relationships within a CMO networkExperience with electronic Quality Management SystemsExperience in conducting or hosting Quality and/or Health Authority audits.Education:·Degree (Bachelors or higher) or equivalent experience in life sciences, Biology, Biochemistry, Chemical Engineering, BiotechnologyRemote working/work at home options are available for this role.

Created: 2025-06-25