Senior Specialist Quality Assurance

4 weeks ago

North Wales, United States Integrated Resources, Inc Full time


" Responsible for executing relevant procedures to ensure Product Quality Complaint (PQC) and Adverse Event Quality Investigation (AE-QIR) intake management processes comply with regulatory expectations.
" Responsible for receipt, processing, and follow-up of Product Quality Complaints or Adverse Event Quality Investigation Requests.
" Acts as an effective liaison between *** support functions worldwide for complaint-handling activities to maintain regulatory compliance.
" Provides expertise in complaint-handling processes and systems to resolve issues and drive continuous improvement.
" Manages the intake of complaint samples for the US market. Identifies appropriate investigating sites, documents sample information, prepares the sample for shipment to the investigating site when designated by LCIU, performs functional testing, and documents all findings in the complaint records.

Quals--
Looking for a Quality Assurance/Complaint Handling Unit Specialist for a 6-month contract. HYBRID ROLE the role requires physical management of complaint samples in our BSL-2 lab, located in Spring House, Pennsylvania.
Be able to open the sample to do a visual inspection and triage and classify them accordingly.
Be able to process and inspect various *** Products like inhalers, syringes, vials, etc.
Have good communication skills to hold productive conversations with multiple cross-functional teams.
Have leadership skills and be able to think critically and analytically.
Have experience with MS Office/Teams.
Good to have experience with software like QCC4 and SAP.

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