Job Description
Title: Senior Specialist, QARequisition ID: 67331Date: Oct 9, 2024Location: Waterford, Munster, IEDepartment: QualityWho We Are:At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.Job Summary:The Senior Associate, Quality Assurance oversees projects, maintains processes and addresses quality issues by analyzing outcomes and collaborating with teams for effective resolutions. This position will continue the QA routine activities of a working WSS lab and QA duties for future business.Essential Duties and Responsibilities:Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.Independently performs supplier audits and corporate facility audits.Manage multiple project tasks and effectively coordinate handling of customer feedback and complaints.Lead assessment and closure of customer complaints, ensuring adherence to established procedures and documentation.Coordinate communication between internal teams and customers.Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication.Reviews, revises, and creates operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual.Ability to lead meetings with customers, employees and contractors as necessary to manage changes.Establish monthly KPI’s and metrics to Quality Leadership.Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources.Education:Bachelor's Degree In Engineering or Science - requiredMaster's Degree In Engineering or Science - preferredWork Experience:Minimum 5 years of experience as Sr Associate is requiredExperience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent)Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF ActivitiesExperience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820Experience Leading Internal / External Audits, MasterControl, SAP and Share PointExperience with customer interface and meeting customer expectations.Preferred Knowledge, Skills and Abilities:Ability to work independently, multi-task and thrive in fast-paced environment.Excellent written and verbal communication skillsProficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power PointProven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485.Familiarity with root cause analysis toolsWorking knowledge of MasterControl and SAPSupport and contribute in Lean Sigma programs and activities towards delivery of the set targetAbility to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team membersAble to be aware of all relevant SOPs as per Company policy and Quality ManualAble to comply with the company’s safety policy at all times.Additional Requirements:Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.Must maintain the ability to work well with others in a variety of situationsMust be able to multi-task, work under time constraints, problem solve, and prioritize.Ability to make independent and sound judgmentsObserve and interpret situations, analyze and solve problemsMaintain high attention to detail, accuracy, and overall quality of work.Effectively communicate and interface with various levels internally and with customers.West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening. #J-18808-Ljbffr