Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.Summary:The position will support the operation of a new, state-of-the-art plasma fractionation facility that will bring Shire additional capacity for testing, purification and fill finish for its biologic medications.QA Associate II is responsible for, but not limited to:Providing Quality oversight and manufacturing support as required by OperationsPerforming timely review of batch record documents on the shop floorIdentifying and assessing regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Shire quality practicesThis is a swing shift position. Essential Duties and Responsibilities: Provides manufacturing floor coverage and attends daily cross-functional departmental meetingsIdentifies nonconformance??s and participates in investigation and Corrective and Preventative Action (CAPA) activitiesUse of Quality Systems to assess product impact or review dataAuthors, review and/or approves written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet requirementsWorking Environment:Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines May be required to work weekends, evenings, off-hours, and extended periods of timeMay be required to travel to local and international work locations for extended periods of time for trainingQualifications:Education and/or ExperienceBachelor??s degree in Engineering, Science or related field or equivalent. 2-3 years of experience required in the pharmaceutical or other similarly regulated industry preferred.Must have the ability to engage in team activities with strong communication and negotiation skillsMust have strong analytical and problem solving skillsMust have knowledge of and understand application of Good Manufacturing PracticesExperience with Trackwise, EBM, and Delta V/PLC is preferred
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