Quality Assurance Specialist - The Fountain Group

The Fountain Group.  We are a national staffing firm and are currently seeking a Quality Assurance Specialist for a prominent client of ours. This position is located in ­­North Whales, PA. Details for the position are as follows:

Details:

**ONSITE/HYBRID ROLE**

• 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 - 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 onsite, but this should not be expected to happen immediately.
• There should be flexibility in coming to the office as and when required.
• This is a 6-month contract, with no guarantee of extension or going perm.

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 client 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:

• Required:
  • BS/MS
  • QA experience
  • Device preferred, pharma is okay
  • Quality Investigations/Deviations
• Preferred:
  • Product Complaints
  • visual inspections/quality inspections (must be comfortable with these duties)
  • QCC4 or SAP
  • inhalers, syringes, vials (organon products)
  • Microsoft

Compensation: Up to $32.79 an hour depending on experience