QA Specialist - The Fountain Group

The Fountain Group is currently seeking a ­­­­­­­­QA Specialist for a prominent client of ours. This position is located in ­­Frederick, MD. Details for the position are as follows:

Job Description:

**ONSITE (4/10 schedule): Sunday-Wednesday 7am-5:30pm**

• Everyone in the company is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?
• We are seeking a highly motivated individual to join us as a Quality Assurance Specialist.
• In this role, you will support the activities of the Quality Assurance department at the Frederick, MD manufacturing site.
• The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and quality objectives.
• Responsibilities (included but not limited to):
  • Provide QA support on the floor for production
  • Ensure process control measures are in place and followed in product manufacturing
  • Receipt and disposition of incoming apheresis material
  • Oversee and authorize shipment of final product
  • Verify and ensure timely issuance of production documents and labels
  • Review batch-related documentation and ensure resolution of issues to release and ship product
  • Gather and report metrics to measure performance
  • Identify continuous improvement actions
  • Ensure timely resolution and escalation of issues
  • Ensure all product-related Deviations are initiated, investigated, and resolved
  • Ensure that associated CAPAs are initiated and resolved, as needed
  • Perform lot closure activities
  • Ensure approval and timely delivery of final product
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
  • Perform other duties as assigned

Qualifications:

• BS (2+ years biotech/pharma preferred)
  • May consider High School Diploma or AA/AS with extensive relevant experience
• GMP Quality Assurance (QA) Experience
  • Experience working on the manufacturing floor
  • CAPAs | Investigations | Deviations | Root Cause Analysis

Compensation: $25-35 per hour depending on education & experience