Senior Specialist Quality Assurance

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

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.