QA Specialist

«out AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Purpose: The Affiliate QA Analyst is responsible for providing quality assurance support for quality system requirements associated with pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements. Responsibilities: Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products. Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Evaluate, analyze and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective. Partner, coordinate and support activities related to product actions in the affiliate. Assist project teams in planning, preparation, review and approval of quality documentation. Participate in the Management Review process for the Region South. Participate in the update the Quality Manual for the Region South Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans. Participate in training and education programs for various aspects of quality assurance. Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions. Quality management of supplier qualification program including performance monitoring for key suppliers. Ensure metrics and KPIs are being met. Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments. Registration and closure of complaints in the Trilogy system for the Region South Batch Record Review and Retention Samples Ensure the use of updated packaging material, both local and imported Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management. Qualifications Qualifications: Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred. 2+ years’ experience in quality assurance, quality oversight or relevant experience. Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations. Knowledge and familiarity with product, process, and both internal and external customer requirements. Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred. Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively. Strong oral and written communication skills needed. English: medium to advance level Excellent interpersonal skills. Strong computer skills and knowledge of enterprise systems such as SolTraqs, Atttache and Attache Pro. Runs small project to deliver tactical results. Key Stakeholders: Local Affiliate Staff, Commercial QA team, Regulatory/Competent Authority, Suppliers/Service Providers. Travel Yes, 5 % of the Time Job Type Apprenticeship Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.