US-GA, Quality Associate I SR0029673-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. Summary: The position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Baxalta additional capacity for testing, purification and fill finish for its biologic medications. Responsible for providing Quality Operations support for the Isolator Filling activities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxalta quality practices. The incumbent will be responsible for handling multiple projects, demonstrating effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. Essential Duties and Responsibilities: Leads ongoing daily departmental Quality Operations for IG filling activities such as electronic batch management development, filling process strategy development, QA filling support activities and other duties as assigned. 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. Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions. 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. Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements and IG filling operations. Provide training and coaching to local employees and others as needed in relevant areas. Write, review, analyze and revise written Standard Operating Procedures (SOP's) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Participate in external assessments and audits by evaluating and solving product/process problems by providing technical and analytical support process with timely closure of observations/audit items. Manage investigations and implementations of low level event and change controls. Oversee, review and audit of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA multi-site projects in the role of contributor, coordinator or lead. Other duties, tasks or projects as assigned. Working Environment: May work in a clean-room environment and wear special garments (requires removal of make-up and jewelry). May wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas. May be required to work weekends, evenings, off-hours, extended periods of time. May be required to travel to local and international work locations for extended periods of time for training. Qualifications Strong interpersonal skills and great attention to detail are necessary. Must be a team player with good problem solving skills , and good verbal and written communication skills. Must have the ability to encourage teamwork and drive decisions. Must be able to handle multiple projects concurrently. Must have adequate computer experience (working knowledge of Microsoft Word, Excel and PowerPoint) Knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices is preferred. Education and/or Experience Associates Degree in business/science or equivalent related experience. 1-3 years' experience in Quality (specifically in a sterile filling support role) with a medical device/Pharma company or other similarly regulated industry.
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Equal Employment Opportunity
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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