Quality Complaints Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Amgen is looking for a Specialist Quality Complaints Standard/Advanced Complaint Owner to join the Product Complaints and Surveillance team.

• The Specialist will lead cross-functional teams in executing complex complaint investigations.

• Identifies corrective actions and assesses their effectiveness.

• Establishes the necessary steps to maintain appropriate control over products in distribution.

• Aligns complaint closure requirements with established process step metrics to guarantee timely record closure.

• Ensures the quality of complaint records.

• Facilitates cross-functional meetings to strategize and coordinate record closure plans.

• Utilizes analytical skills and product knowledge to assess complex situations using various information sources.

• Completes prioritized work plans efficiently.

• Proactively escalates issues that may hinder the ability to close records per action plans.

• Maintains compliance with both local and global processes.

• Executes regulatory and standard operating procedure (SOP) requirements.

• Anticipates and mitigates potential issues with regulatory bodies.

• Offers guidance and technical advice as needed.

• Evaluates assessments from subject matter specialists.

• Brings potential quality concerns to the attention of management.

⛳️ Requirements

• Doctorate degree OR Master’s degree with 2 years of quality experience OR Bachelor’s degree with 4 years of quality experience OR Associate’s degree with 8 years of quality experience OR High school diploma/GED with 10 years of quality experience.

• A minimum of 4 years of experience in quality and manufacturing within the biotech or pharmaceutical industry.

• Bachelor’s Degree in a Science Field.

• Capability to manage multiple projects concurrently.

• Proficient in managing workloads to meet timelines successfully.

• Familiar with basic project management tools.

• Ability to negotiate positions after considering feedback from various sources.

• Understanding of relevant manufacturing/testing processes (e.g., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

• Willingness to travel +/- 10% of the time to domestic and international Amgen locations.

🏝️ Benefits

• A comprehensive benefits package for employees, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.