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Specialist Quality Complaints

Company: Amgen
Location: Somerville
Posted on: October 8, 2020

Job Description:

Career CategoryOperationsJob DescriptionAmgen is seeking a Specialist Quality Complaints Level 2 / Level 3 Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.Key Responsibilities:Ensures quality of complaint recordsFacilitate cross-functional meetings to plan and coordinate the plan for closure of recordsApplies analytical skills and product knowledge to evaluate complex situations using multiple sources of information            Executes against prioritized work plansQuickly escalates issues that could impede the ability to close records according to action plansMaintains compliance with local and global processesExecution of regulatory and SOP requirementsAnticipates and prevents potential issues with regulatorsProvides guidance and technical adviceEvaluates subject matter expert assessmentsEscalates potential Quality issues to ManagementBasic Qualifications Doctorate degreeORMaster’s degree & 3 years of Quality / Manufacturing experienceORBachelor’s degree & 5 years of Quality / Manufacturing experienceORAssociate’s degree & 10 years of Quality / Manufacturing experienceORHigh school diploma / GED & 12 years of Quality / Manufacturing experiencePreferred Qualifications 4+ years of quality and manufacturing experience in biotech or pharmaceutical industryBachelor’s Degree in a Science FieldAbility to oversee multiple projects simultaneouslyAbility to successfully manage workload to timelinesFamiliarity with basic project management toolsAbility to negotiate a position after taking feedback from multiple sourcesDemonstrated ability to consistently deliver on-time, and high-quality resultsAbility to operate in a matrixed or team environmentUnderstanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)Ability to travel +/- 10% of time to domestic and international Amgen sitesAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status..Full time

Keywords: Amgen, Somerville , Specialist Quality Complaints, Other , Somerville, Massachusetts

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