Quality Specialist I, Compliance & Quality Systems

Why Endo? We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.Job Description SummaryJob DescriptionThe Quality Specialist I, Quality Operations contributes to various aspects of quality systems, such as Product Complaints, Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events. Assists with various aspects of development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.Responsible for CMO/CPO Quality Operations and Quality Systems for Change Control, CAPA, routine Deviations and Investigations.Quality OperationsAssesses risk level associated with NCRs, and escalates to management.Assists with various aspects of development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.Communicates due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time.Contributes to various aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.Monitors stability program ad ensures gathering of data out of specification investigations and summary reports are timely and compliant.60%Quality Documentation/Report ReviewPrepares controlled documents (e.g. SOP’s, APRs) required for compliance.Completes assigned duties and responsibilities (filing, etc.).20%Continuous ImprovementSupports self-audit checks and evaluates CAPA effectiveness checks.10%Inspection ReadinessAssists in the preparation of materials for inspection readiness and management review.10%QualificationsEducation & ExperienceBachelor’s degree in a scientific related field with a minimum of 0-2 years’ relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry.Technical and quality background related to the sciences.KnowledgeGeneral understanding of all current state, federal, and local US and EU standards and regulations (ICH, EU GMPs, US CFRs, ISO, etc.).Working knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.Skills & AbilitiesGood verbal and communication skills required.Attention to detail required.Demonstrated excellent interpersonal skills and flexibility.Ability to handle multiple priorities in a fast paced environment.Good writing skills.Strong organizational skills.Ability to build peer relationships.Physical RequirementsRoutine office work (sit/stand).Business travel occasionally as needed..Commitment to Diversity, Equity, and Inclusion: At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.