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Sr Specialist, Quality
Sr Specialist, Quality-December 2024
Exton
Dec 19, 2024
About Sr Specialist, Quality

  Reference #: 974867501ONSITE ROLE IN EXTON, PAWho We AreAt 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:This position is responsible for all stages of receiving customer complaint, interacts with customer for additional information, acting as a liaison with plant QA, TCS, Sales, Order Fulfilment, Data Governance, and other areas necessary to satisfy customer's expectations. It leads and manages the customer complaint process to ensure that the system is in place and procedure is being followed. Complies customer complaint specific data as needed to support customer's review meeting in general.Essential Duties and Responsibilities:Provide support to Quality group ensuring consistent application of procedures in placeManage key projects/initiatives related to customer complaints and ensures that progress is within expected guidelines and timelines.As the point of quality contact when receiving customer complaints, performs a variety of duties such as assembling all information (customer and West), coordinating and managing multidisciplinary technical review teams (Lab, TCS, QS, etc) when necessary for critical complaintsAid initial receipt, review, trending and impact assessments for customer complaint issuesReceive and proper handling of customer complaint and compliant samples in the West SystemEnter customer complaints in SAP.Coordinates and manages day-to-day operations and communications with customer and internal departments/plants to ensure all information is available on time to perform customer complaint investigationEnsure all customer information necessary to initiate the investigation is received and recorded accordinglyFacilitate communication between West and customer on complaint critical issues and aid the plant in preparation for the meeting and ensure expectation is alignedCoordinate customer credit for complaints involving return and credit dispositionWork with QA sites and Exton Lab personnel to meet target customer satisfaction goals on investigation response timeIdentify opportunities for improvement on complaint process in generalReview complaint data, analyzes results and recommends changes based upon findings. Prepare customer specific complaint data and trend as requestedPrepare report by collecting, analyzing and summarizing data, making recommendConforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.Exhibits regular, reliable, punctual and predictable attendance.Other duties as assignedBasic Qualifications:Education: Bachelor's or equivalent work experienceExperience: Minimum 5 years of experience in Quality and/or customer complaint systemPreferred Knowledge, Skills and Abilities:Attention for detail and deadline drivenStrong verbal and written communication skillsWorking familiarity with root cause investigation toolsAbility to work independently, multi-task and thrive in fast-paced environmentA sense of urgency/initia iveDemonstrate team building and problem-solving skillsKnowledge of cGMP requirements and ISO standardsAbility to effectively prioritize and escalate issuesExperience with customer interface and meeting customer expectationsTravel Requirements:Up to 5% travel, minimalPhysical & Mental Requirements:Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time.  Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are metAbility to comply with quality and safety policiesAbility to effectively communicate and comprehend complex ideas and concepts.Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machinesMust be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to proceduresOrganizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activitiesPosition operates in a professional office environment. May stand or sit for extended periods of timeRead and interpret data, information and documentsMust 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 problems#LI-DJ1West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

  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 disability or special need that requires accommodation, please send an email to [email protected].

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