Sr Quality Specialist, Systems

The Senior Quality Specialist, Systems monitors, tracks, and trends Non-Conformances, CAPA, complaints and other Quality Systems, assesses the risk level associated with Non-Conformances and escalates the issue to management. Gathers, analyzes, reports, and presents metrics to the Quality Systems and Technology Department for the corporate Quality Index. Reviews or approves the Site Quality Review for complaint investigations and monitors complaints to ensure that potential field alerts are investigated within 72 hours. May attend meetings in place of the Manager Quality Systems and determines priorities and makes appropriate decisions. The job requires coordination with different departments within the respective site as well as the Quality Systems and Technology department to ensure compliance to current Standard Operating Procedures for the Quality Systems defined within the corporation and government regulations. All incumbents are responsible for following applicable Division & Company policies and procedures. Scope of Authority - Manages the Quality Systems at his/or her site as well as metrics, but may also assist other sites with metrics on an as needed basis Key Accountabilities - % of Time Continuous Improvement Monitors, tracks, and trends CAPA and complaints, tracks due dates, analyzes data, prepares reports, and presents findings 40% Compliance Assesses risk level associated with NCRs, notifies Planning/Scheduling, and escalates to management Reviews or approves Site Quality Reviews of complaint investigations and monitors complaints to ensure that potential field alerts are investigated within 72 hours Attends meetings as requested in place of the Manager Quality Systems and determines priorities and makes appropriate decisions 20% Initiates communication due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time Reviews current Quality Systems, works with cross functional teams and recommends improvements 20% Management Review Coordinates and prepares metrics and materials for Quality Council and Management Review 15% Continuous Improvement Performs and evaluates CAPA effectiveness checks 5% Qualifications - Education & Experience BA/BS preferably in life sciences plus a minimum of 6 years’ experience in the pharmaceutical industry OR MS 4 years’ relevant experience in pharmaceutical industry Knowledge Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines Technical and quality background related to pharmaceuticals Skills & Abilities Strong communication skills Strong focus on quality and proven ability to apply a high degree of integrity Customer/Stakeholder focused (understand business plans and operating environment) Technical Writing ability Clear problem-solving and decision-making skill Physical Requirements Walk across plant/warehouse Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000 global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.