Specialist Quality Complaints

Amgen Specialist Quality Complaints Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What You Will Do Amgen is seeking a Specialist Quality Complaints Standard/Advanced Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and carries out 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 records Facilitate cross-functional meetings to plan and coordinate the plan for closure of records Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information Completes prioritized work plans Quickly advances issues that could impede the ability to close records according to action plans Maintains compliance with local and global processes Execution of regulatory and SOP requirements Anticipates and prevents potential issues with regulators Provides guidance and technical advice Evaluates subject matter specialist assessments Raises potential Quality issues to Management What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of quality experience OR Bachelor's degree and 4 years of quality experience OR Associate's degree and 8 years of quality experience OR High school diploma / GED and 10 years of quality experience Preferred Qualifications: 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry Bachelor's Degree in a Science Field Ability to oversee multiple projects simultaneously Ability to successfully manage workload to timelines Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding 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 sites What You Can Expect From Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. Amgen