Senior Specialist Quality Assurance

3 weeks ago

Spring House, United States Integrated Resources, Inc Full time

Job Title: Senior Specialist Quality Assurance - Level II (Associate)

Job Location: Spring House, PA

Duration: 6 Months

Pay range: $28 - $32/Hour. on W2

Additional Site Info:

· 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.

Job Description:

· 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.

Qualifications:

· 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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