Specialist Quality Complaints- 35405
About The Position
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. Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations. 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. 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. 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.
Requirements
- Doctorate or Masters + 2 years of directly related experience
- Bachelors + 4 years of directly related experience
- Associates + 8 years of directly related experience
- High school/GED + 10 years of directly related experience
- Strong project management skills
- Experience leading cross-functional teams
- Ability to handle multiple projects simultaneously
- 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
- Self-motivated
- Able to interface effectively with various levels
- Attentive to details
- Able to prioritize and meet deadlines
- 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
- Collaborate with outside resources
- Ability to evaluate issues, make decisions and determine when to escalate, as necessary
Nice To Haves
- Bachelor in engineering (preference Industrial)
- Master in science related
- Experience in project management
- Root cause analysis
- CAPAs determination
- Quality mind set and deep compliance knowledge
- Proficient in Microsoft Office Program (Excel, outlook)
- Usage of Team
- Proficient in Artificial intelligence programs (ChatGPT)
Responsibilities
- Supporting the product complaint system at Amgen
- 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
- Keeping the complaints database updated as soon as factual information is available
- Summarizing closed investigations into the database accurately
- Reviewing and approving complaint related investigations to ensure they are concise, clear and science-based
- Following up on corrective actions derived from investigations through completion
- Conducting and documenting investigations (on occasion)
- Communicating and escalating complaints
- Representing the site on the product complaint network
- Generating and issuing closure letters to patients and business partners
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
