Quality Assurance Specialist

Job Summary

Responsibilities

• Manage customer complaints, product quarantines, recoveries, change notifications, and quality surveys.
• Lead investigations with suppliers and cross-functional teams to identify root cause and implement corrective actions (CAPA).
• Collect, analyze, and report quality metrics using systems like Oracle and quality management databases.
• Draft and revise QA standard operating procedures and work instructions.
• Participate as an internal auditor for the Quality Management System and support Practical Process Improvement (PPI) initiatives.

Qualifications

• Required: Bachelor's degree (or equivalent experience) in engineering, chemistry, biology, mathematics, or a technical field.
• 2+ years of experience working in an ISO (13485 preferred) or FDA cGMP-regulated environment.
• Proven experience in customer/supplier quality interactions and root cause analysis.
• Proficiency with continuous improvement tools and methodologies (e.g., Six Sigma, PPI, Lean, CAPA).
• Ability to work on-site in Greenville, NC on a 2-2-3 day rotation (6 AM-6 PM) with up to 15% travel.

Preferred Experience

• As an internal or lead auditor.
• Hands-on experience with quality systems like MasterControl or SalesLogix.

Skills

• Biology
• Chemistry
• Good Laboratory Practices (GLP)
• Good Manufacturing Practices (GMP)
• Quality Assurance (QA)
• Quality Control (QC)
• Aseptic Processing

Benefits

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term disability
• 401K plan