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Musculoskeletal Transplant Foundation Quality Assurance Technician in Jessup, Pennsylvania

Quality Assurance TechnicianJob LocationUS-PA-JessupTypeFull-TimeCategoryQualityShift1st ShiftJob ID2021-5210Overview/RisksPerforms and documents daily, weekly, and monthly environmental monitoring activities within a strict ISO Class clean room environment in accordance with MTF procedure and Work Instructions, applicable US FDA regulations, Australian TGA Regulations, AATB Standards and other applicable governmental regulations. Environmental sampling results are used to determine clean room are operating in accordance to written specifications and determining the final release of processed tissues/devices. Enivronmental sampling is extremely time sensitive due to the biologic nature of the samples obtained. Develops technical raw material specifications for assessing and approving incoming supplies and materials used for the aseptic processing and testing.Performs technical review and approval of certificates of conformance for critical incoming processing supplies and laboratories supplies and materials to ensure compliance to established specifications. Packages, documents, and ships required samples to internal and external laboratories for testing.ResponsibilitiesOperates critical, highly specialized air sampling equipment within a strict aspeptic clean room environment and ensures equipment is working as intended and is appropriately calibrated. Operation of sampling equipment and obtaining environmental samples requires a high degree of dexterity while aspetically gowned and gloved. Maintains strict aseptic technique at all times within an ISO Class aseptic clean room processing environment to prevent contamination and cross contamination of the environment and the tissue/device.Performs critical, time senstive environmental sampling of the MTF clean room aseptic processing facility including, but not limited to; non-viable air sampling, viable air and surface sampling, water and LAL sampling, and nitrogen system testing per MTF procedure and work instructions. 2.1 Non-viable sample results are available immediately. If results are not meeting MTF specification requirements, QA technician assesses the clean room environment, completes appropriate documentation, decides if immediate correction action can be implemented, and notifies the appropriate required individuals. Discusses with QA management and assists with implementing additional corrective actions at a later time if required.2.2 Viable testing samples, water and LAL samples, and nitrogen testing samples are taken as per procedure. QA technician completes the appropriate documentation, packages the samples properly, and ships the samples to the appropriate testing laboratory in a timely manner. When result is available and not meeting MTF specification requirements, discusses with QA management and assists with implementing corrective actions.2.3 Assists in providing weekly or monthly trending and reporting of environmental testing data.2.4 Generates any necessary nonconformance reports, performs the necessary investigations, directs any necessary actions, completes the required documentation, and follows up to ensure the nonconformance is resolved in a timely manner if requested by QA management.Develops technical raw material specifications for assessing and approving incoming supplies and materials used for the aseptic processing and testing.Performs technical review and approval of certificates of conformance for critical incoming processing supplies and laboratories supplies and materials to ensure compliance to established specifications. Packages, documents, and ships required samples to internal and external laboratories for testing.Generates any necessary nonconformance reports, performs the necessary investigations, directs any necessary actions, completes the required documentation, and follows up to ensure the nonconformance is resolved in a timely manner.Documents, reconciles, packages and ships samples to appropriate testing facility in a timely

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