Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Select how often (in days) to receive an alert: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 SummarySr Assoc, Quality Systems is responsible for leading the coordination of Change Control activities and ensuring compliance with internal and external Change control requirements. The role will serve as the subject matter expert and administrator for change control documentation.Essential Duties and ResponsibilitiesOversee overall global Change Control process; leading change control review board activities (documentation, data, customer notifications and approvals, etc.)Collaborate with cross functional teams on West change controls and provide guidance and Quality consultation to change control owners on change levels and associated tasks.Assist change owners to outline action plans, tasks and responsibilities to ensure execution of changes occur in a timely mannerDrives visibility and oversight to changes across network to ensure applicability and consistency.Oversees assessment of change controls and assures change Impact is considered across products, platforms, life cycle phases, supply chain, and processes (i.e. combination products).Ensure change control information is accurately entered into the appropriate tracking databaseProvide mentoring and training to change owners on change control processes and toolsWork with global, cross-functional groups, manufacturing sites, and customers as needed to determine compliance with customer specifications.Monitor and communicate metrics and trend reports to management for the Change Control system as neededCollaborate on cross functional teams in determining specification content.Perform evaluation of change control processes and tools to drive continuous improvement activities.Additional ResponsibilitiesEnsure adherence to corporate Quality System requirementsEducationBachelor's Degree in Science or equivalent experience required andMaster's Degree in Science or equivalent experience preferredWork ExperienceMinimum 5 years of experience in regulated Quality Assurance / Quality Control required andExperience with qualifications, Quality Risk Management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities, MasterControl, SAP, Share Point, Teamcenter preferredPreferred Knowledge, Skills and AbilitiesAbility to work independently, multi-task and thrive in fast-paced environmentExcellent critical reading and writing skillsMust have effective problem solving and interpersonal skillsAbility to work independently, multi-task and thrive in fast-paced environmentProblem solving including root cause failure analysis methodsPlanning/organizational skillsProficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power PointAble to comply with the company’s safety policy at all timesKnowledge of cGMP, cGDPLicense and CertificationsTravel Requirements5%: Up to 13 business days per yearPhysical RequirementsSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.Additional RequirementsAdaptable 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 prioritizeAbility 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.Able to be aware of all relevant SOPs as per Company policy and Quality ManualWest 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 orderto 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.
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