US-GA, Quality Assurance Associate II - Packaging SR0030925-MZ
Takeda 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. Leads ongoing, daily departmental operations. May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports. Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans. Provide quality oversight for packaging operations, including control of printed materials, visual inspections, verification of labels and product packaging, perform AQL inspections, Batch Record review- meeting requirements of CFR 21. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Support external assessments or audits. Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Serve as Subject matter Expert (SME) and provide training to local employees as needed on packaging are compliance. Serves as SME for Visual Inspection Certification and maintains vial defect sets. Other duties, tasks or projects as assigned. Requirements: Must have 20/20 corrected vision. This position requires the ability to pass eye exam including depth perception and color blindness testing. Hiring is dependent on the ability to pass visual exam and visual inspection qualification. Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to manage people, encourage teamwork and drive decisions. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate. Qualifications: Associate degree in business/scientific discipline and one to three years of relevant experience. Bachelor s degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred. May require shift work. Experience with visual inspection certification and packaging operations in biopharmaceutical industry preferred.
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Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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