Specialist Manufacturing Drug Product Investigation Support

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.
• Cook up cross-functional activities with Manufacturing, Quality Assurance, Process Engineering, Process Development, Quality Control, and other support functions.
• Aid in 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 escalate potential timeline risks when needed.
• Develop and maintain minor deviation metrics and reports to provide visibility into the status, cycle times, and compliance performance.
• 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.

Requirements

• Doctorate degree in related field OR Masters degree and 2 years of manufacturing experience OR Bachelors degree and 4 years of manufacturing experience OR Associates degree and 8 years of manufacturing experience OR High school diploma / GED and 10 years of manufacturing experience

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.

Skills

• Strong project coordination and organizational skills.
• Excellent written and verbal communication skills.
• Strong attention to detail and technical documentation skills.
• Ability to work effectively in a cross-functional matrix environment.
• Knowledge of GMP regulations, deviation management, investigation processes, and CAPA systems.

Benefits

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.