Specialist QA-External Product Complaints
Amgen Inc
hace 72 días

The position will be responsible for triaging and investigating complaints integral to the design, manufacture, delivery and service of our products.

Interact with and communicate with internal and external customers while meeting regulatory compliance and its required documentation.

Investigate complaint records, process and close complaints while following company procedure.

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 for 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. Position may reside at any Amgen location.

Responsibilities :

  • Interact and communicate with internal and external customers for reporting of complaints and adverse events (this may include intake and / or follow up requests for information.)
  • Ensure that all complaints requiring customer responses are properly addressed as assigned.
  • Understands the complaint handling process from initiation to closure.
  • Process and close complaints in a timely manner.
  • Maintain current knowledge of the Regulatory regulations
  • Serves as an internal review in order to assure regulatory compliance across all product lines.
  • Other duties as assigned.
  • Basic Qualifications : Doctorate degree

    Doctorate degree

    Master’s degree and 3 years of Quality or Operations experience

    Bachelor’s degree and 5 years of Quality or Operations experience

    Associate’s degree and 10 years of Quality or Operations experience

    High school diploma / GED and 12 years of Quality or Operations experience

    Preferred Qualifications :

    Master’s Degree and 5+ years of Product Complaints experience

    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

    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

    Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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