Specialist Manufacturing - Drug Product Investigation Support

Specialist Manufacturing - Drug Product Investigation Support In this vital role, you will support the Drug Product Manufacturing Investigation Team within the Amgen Thousand Oaks Clinical Supply Organization. This position is responsible for assisting with the coordination, execution, and timely completion of minor and major manufacturing deviation investigations. Responsibilities Support the Drug Product Manufacturing Investigation Team by assisting with the execution and timely completion of manufacturing deviation investigations. Assist investigation owners with gathering information, attending investigation related meetings, documenting findings, and tracking investigation deliverables. Manage the scheduling, prioritization, and timely completion of minor manufacturing deviations while supporting the coordination of major investigations. Author and own minor manufacturing deviations, including documenting the event, performing the required assessment, and ensuring timely completion in accordance with quality system requirements. Coordinate cross-functional activities with Manufacturing, Quality Assurance, Process Engineering, Process Development, Quality Control, and other support functions. Assist with data collection, trend analysis, and documentation needed to support root cause analysis, product impact assessments, and CAPA development. Track investigation milestones, CAPAs, and action items through closure and elevate potential timeline risks when needed. Develop and maintain minor deviation metrics and reports to provide visibility into the status, cycle times, and compliance performance. Support continuous improvement initiatives focused on investigation processes, compliance, and operational efficiency. Maintain accurate and compliant documentation within electronic quality management systems. Support the investigation team with inspection and audit readiness activities, including investigation support and documentation. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a highly organized and collaborative individual with strong project coordination, communication, and problem-solving skills. Basic Qualifications Doctorate degree OR Master’s degree and 2 years of manufacturing experience OR Bachelor’s degree and 4 years of manufacturing experience OR Associate’s degree and 8 years of manufacturing experience OR High school diploma / GED and 10 years of manufacturing experience Preferred Qualifications 3+ years of experience in GMP manufacturing, quality systems, investigations, or related pharmaceutical/biotechnology operations. Experience supporting manufacturing investigations, deviations, CAPAs, or quality systems. Strong project coordination and organizational skills with the ability to manage multiple priorities simultaneously. Experience tracking quality records and driving activities to completion within established timelines. Excellent written and verbal communication skills. Strong attention to detail and technical documentation skills. Ability to work effectively in a cross-functional matrix environment and build strong partnerships. Knowledge of GMP regulations, deviation management, investigation processes, and CAPA systems. 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. Benefits 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. Equal Opportunity Employment 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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. #J-18808-Ljbffr Amgen SA