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- Execute relevant procedures to ensure compliance of Product Quality Complaint (PQC) and Adverse Event Quality Investigation (AE-QIR) intake management processes with regulatory expectations.
- Receive, process, and follow-up on Product Quality Complaints or Adverse Event Quality Investigation Requests.
- Act as an effective liaison between Organon support functions worldwide for complaint-handling activities to maintain regulatory compliance.
- Provide expertise in complaint-handling processes and systems to resolve issues and drive continuous improvement.
- Manage the intake of complaint samples for the US market, including identifying appropriate investigating sites, documenting sample information, preparing samples for shipment, performing functional testing, and documenting findings.
- Collaborate with relevant stakeholders to ensure efficient and effective complaint resolution and investigation.
- Scientific background
- Good leadership and communication skills.
- Strong analytical skills.
Quality Assurance Specialist - Ambler, United States - Astrix
Description
Our pharmaceutical client is seeking a Quality Specialist to join their team. The ideal candidate will have a scientific background with quality experience.
Location: Ambler, PA
Pay: $28-$32 per hour
Type: Contract
Responsibilities
Requirements