Quality Assurance Specialist - The Fountain Group

The Fountain Group is currently seeking a ­­­­­­­­Quality Assurance Specialist for a prominent client of ours. This position is located in ­­North Chicago, IL. Details for the position are as follows:

Job Description:

**HYBRID ROLE (3 days onsite, 2 days remote)**

• Overview:
  • Individual will work in Client’s global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries.
  • Interface with internal Client customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding Client product complaints.
  • Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events.
  • Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
• Responsibilities:
  • Assure complaint records meet global requirements.
  • Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
  • Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
  • Identification of potentially reportable events and notification to appropriate functional groups and management.
  • Interface with Third Party Manufacturers, health care professionals, general public, internal customers, Client functional areas and regulatory agencies.

Qualifications:

• BS (life science or engineering)
• Laboratory Experience (GMP experience highly preferred)
• Microsoft Excel Proficiency (pivot tables preferred)
• Good Analytical Skillset (able to read and analyze data, identify issues)
• **Pharma, medical device, and/or complaints experince is a plus**

Compensation: $23-28 per hour depending on experience