Shire Quality Assurance Specialist II in Social Circle, Georgia
Execute activities as part of the Quality Control Investigation team to ensure the safety and reliability of Baxalta products are in compliance with quality and regulatory requirements. Complete robust investigations that determine accurate root causes and effective corrective and preventive actions that mistake proof against the root causes. Support Contamination Control Master Plan (CCMP) initiatives. Interface with Manufacturing, Quality Assurance, and Quality Systems to support product fulfillment and regulatory requirements. Continuously drive the application of Lean and Six Sigma principles to the floor level through activities such as Kaizen, Six Sigma projects and VIPs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Conduct thorough investigations and complete associated nonconformance events (CAPA, OOL, and OOS) in an effective and timely manner in accordance with cGMP and quality systems. Ensure extension requests are completed in a timely manner.Conduct associated investigations to meet product fulfillment dates.Work closely with other Quality, manufacturing, and support departments to conduct investigations, determine appropriate corrective actions, and drive closure of non-conformances.Lead and/or support problem solving sessions through application of various problem solving tools and methods. Will lead routine investigations and may be required to lead complex investigations (such as CAPA investigations).Conduct investigative audits of manufacturing areas and/or personnel as required.Perform investigative sampling of manufacturing areas as required.Prepare and present trend analyses to management during routine operating mechanisms.Audit and update, as required, plant SOPs.Support Contamination Control Master Plan (CCMP) initiatives for environmental and product bioburden to organize and streamline all of the required contamination control elements and mitigate risk to product.Support laboratory audit readiness efforts with understanding of FDA, Shire, and other regulatory and quality requirements.Maintain data integrity and ensure compliance with company SOP’s and specifications, FDA, GLP, QSR, and cGMP regulations.May serve as mentor to other Quality Laboratory positions. Provide training and work direction for Quality Control II and I positions as required.Actively contribute to a team setting within the Laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.Work with minimal Supervision.Adhere to company work rules, policies and safety standards including ensuring personal training requirements are met and that training records are current.
Drive Lean principles such as 6S throughout daily work activities.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.