Description:
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. Functions: 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.
Education:
Doctorate degree in Sciences or Master’s degree & 3 years of investigation experience or Bachelor’s degree in Sciences & 5 years of investigation experience.
Preferred Qualifications:
The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.
Key Responsibilities:
Ensures quality of complaint records
Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
Executes against prioritized work plans
Quickly escalates issues that could impede the ability to close records according to action plans
Maintains compliance with local and global processes
Execution of regulatory and SOP requirements
Anticipates and prevents potential issues with regulators
Provides guidance and technical advice
Evaluates subject matter expert assessments
Escalates potential Quality issues to Management
Skills:
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.
