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Senior Specialist Quality Assurance

4 months ago

North Wales, United States eTeam Inc. Full time
Senior Specialist Quality Assurance - Level II (Associate)
Lower Gwynedd Township, PA 19002
6 Months contract
Pay Rate: $32.79/hr on w2

" 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 organization 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 organization 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.

During the contract's start, the person will be on site every day, this could be at least a month but is subject to change and the contractor should be comfortable coming to the office beyond that as well if need be. Eventually, it will move to 3 days a week on site but this should not be expected to happen immediately. There should be flexibility in coming to the office as and when required.