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Senior Specialist Quality Assurance

Quality Assurance
Lower Gwynedd , PA, US
Pay Rate Low: 31 | Pay Rate High: 32
  • Added - 25/04/2024
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Job Description:

  • 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.

Qualifications:

  • Background in Science.
  • Good leadership and communication skills.
  • Strong analytical skills.
The role initially fully onsite, and eventually transitions to 3 days onsite per week.
This is a 6-month contract position.
Pays up to 
$32.80

INDBH