Specialist QA AFP

Location: Thousand Oaks, CA
Date Posted: 10-06-2017
Day to Day 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

Summary:
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/Licenses:
Doctorate degree or Master’s degree & 3 years of experience directly related to the job or Bachelor’s degree & 5 years of experience directly related to the job

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