Specialist Quality Complaints

Amgen • Thousand Oaks, CA

1d • $108,953 - $135,219 • Remote

About The Position

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. 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. Specialist Quality Complaints What you will do and what we expect of you Let’s do this. Let’s change the world. In this vital role you will: Duties: Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies’ guidelines; Evaluate subject matter expert assessments; Provide guidance and technical advice to conduct complex complaint investigations, determine corrective actions, and determine steps necessary to ensure the proper level of control for product in distribution; Ensure quality of complaint records and applies analytical abilities to evaluate complex situations using multiple sources of information; Execute against prioritized work plans to ensure timely investigation and closure of records in adherence with pre-determined process step metrics; Provide feedback and guidance to improve quality performance and prevent recurrence of issues; Develop solutions to technical problems of moderate complexity; Screen, evaluate, report and resolve record integrity issues; Raise potential Quality issues to Management and intensify issues that could impede the ability to close records according to action plans. Support department continuous improvement activities and projects in accordance with applicable regulations and business goals and objectives; Serve as a Subject Matter Expert for the team, responsible for reviewing device investigation reports and ensuring proper investigation; Support product hypercare by compiling and reviewing data; Representing the electromechanical team and working with the AI pilot project for the complaints process optimization; Direct discussions to define the scope of the Root Cause Analysis and Supplier Corrective Actions, ensuring a thorough and strategic approach to issue resolution. May telecommute.

Requirements

• Master’s degree (or foreign equivalent) in Industrial Engineering or related field & 2 years of experience in the job offered or in an engineering-related occupation.
• Position requires 2 years of experience in the following:
• Manufacturing testing processes, including API, Drug Substance, Drug Product, Packaging, and Device manufacturing processes
• Quality and manufacturing experience in biotech or pharmaceutical industry
• Quality Management Systems including Salesforce, Trackwise, or SAP
• Electronic Document Management Systems including Veeva Vault Quality, Box, and Share point
• Global regulations including FDA 21 CFR 820, International Organization for Standardization ISO 13485, FDA cGMP, and Device cGMP Regulations to align with regulatory guidelines during processing product complaints
• Operating project management tools including Microsoft Office, Smartsheet, or Miro
• Identifying and escalating Quality Defects, and communicating with contract manufacturing organizations or suppliers.

Responsibilities

• Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies’ guidelines
• Evaluate subject matter expert assessments
• Provide guidance and technical advice to conduct complex complaint investigations, determine corrective actions, and determine steps necessary to ensure the proper level of control for product in distribution
• Ensure quality of complaint records and applies analytical abilities to evaluate complex situations using multiple sources of information
• Execute against prioritized work plans to ensure timely investigation and closure of records in adherence with pre-determined process step metrics
• Provide feedback and guidance to improve quality performance and prevent recurrence of issues
• Develop solutions to technical problems of moderate complexity
• Screen, evaluate, report and resolve record integrity issues
• Raise potential Quality issues to Management and intensify issues that could impede the ability to close records according to action plans.
• Support department continuous improvement activities and projects in accordance with applicable regulations and business goals and objectives
• Serve as a Subject Matter Expert for the team, responsible for reviewing device investigation reports and ensuring proper investigation
• Support product hypercare by compiling and reviewing data
• Representing the electromechanical team and working with the AI pilot project for the complaints process optimization
• Direct discussions to define the scope of the Root Cause Analysis and Supplier Corrective Actions, ensuring a thorough and strategic approach to issue resolution.

Benefits

• this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation
• 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, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level