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Specialist Quality Complaints

Newbury Park, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”
                                                            
Top 3 Must Have Skills
  • 5 years of biopharmaceutical experience
  • Quality Complaint Processing experience or Quality Assurance
  • Communication both Oral and written expertise
  • Problem-solving and Critical thinking
  • Experience investigating deviations a plus

Day to Day Responsibilities:
FUNCTIONS
1. Candidate will be responsible for; ensuring complaints are accurately entered into the complaints database in a timely manner, complaints are assessed according to SOP's, escalates issues related to nonconformance, manages timely communication and follow-up of critical complaints, generate and distribute customer response letters.
2. Candidate will also be responsible for working with other Amgen departments, contract partners and call centers to resolve discrepancies/deficiencies.
3. Additional responsibilities include prioritizing complaints and understanding the importance of accurate data entry of complaints within the required timeframe, notifying appropriate parties upon receipt of complaints, supporting the complaints returns process by determining follow-up required for complaint return samples and documentation of communication attempts, partnering with call centers providing tactical oversight and support, providing written communication to senior management and team members, and performing other duties as assigned by supervisor.
Employee Value Proposition:    
The person in this role will manage and decide assessments on complaints. You will lead teams in crossfunctional discussions.


"This posting is for Contingent Worker, not an FTE"

 

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