Under minimal, if any, supervision, contributes to the execution of complaints investigation projects necessary to achieve corporate and departmental goals.
1. Support the product complaint system at Amgen through; leading and managing product complaint investigations,
2. Perform data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
3. Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
4. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
5. Follow-up on corrective actions derived from investigations through completion.
6. Responsible of conducting and documenting the investigation.
7. Close the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
8. Lead investigations.
9. In-depth knowledge of fill/finish operations, incoming component, inspection/disposition, effective decision making and influencing skills, and ability to manage a large number of complex projects simultaneously.
10. Analyze data, conduct thorough root cause analysis and implement effective corrective actions.
11. Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
*Other functions may apply
Doctorate degree and 2 years of directly related experience
• Master’s degree in Engineering or Sciences and 6 years of directly related experience
• Bachelor’s degree in Engineering or Sciences and 8 years of directly related experience
• Excellent written and verbal communication skills including technical writing skills.
• Ability to work in a team or matrix environment
• Ability to collaborate and coordinate with internal and external depts./groups/resources.
• Analytical problem solving skills
• Ability in handling multiple and complex responsibilities, tasks and projects simultaneously.
• Ability to effectively influence and persuade others in a tactful manner.
OTHER PREFERRED QUALIFICATIONS
• Bachelor’s degree in Engineering or Sciences. Advanced degrees preferred.
• At least eight (8) years of biopharmaceutical experience with increasing 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.
• Experience in product complaints processing and investigation, preferred
• 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
• The successful candidate must 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.
• Additional requirements include proven 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.
Amgen - 19 months ago
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