Primary responsibilities include: Supporting the product complaint system at Amgen through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
1. Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
2. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
3. Follow-up on corrective actions derived from investigations through completion. On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
4. Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
5. May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
• Doctorate degree
• Master’s degree in Engineering or Sciences & 3 years of experience directly related to the job
• Bachelor’s degree in Engineering or Sciences & 5 years of experience directly related to the job
• Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
• Excellent written and verbal communication skills, including facilitation and presentation skills.
• Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups
Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
• Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.
OTHER PREFERRED QUALIFICATIONS
• 5 years of biopharmaceutical experience responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
Experience in leading and managing investigations (deviations and/or complaints)
Experience achieving results and in identifying areas of process improvement.
Understanding of biopharmaceutical bulk and drug product manufacturing and distribution processes.
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.
• Masters degree preferred.
• Experience in product complaints processing and investigation preferred