Quality Specialist – Investigations & CAPA (Contract)

Key Responsibilities

• Monitor the site investigation and CAPA process to ensure timely completion and compliance with established quality procedures.
• Cook up investigation activities, ensuring appropriate ownership, accountability, and adherence to required timelines.
• Track, trend, and analyze investigation and CAPA data to identify recurring issues and opportunities for continuous improvement.
• Prepare and maintain investigation and CAPA metrics for Quality leadership and management review.
• Support CAPA Review Board meetings and lead discussions as needed.
• Partner with cross-functional teams to drive timely investigation completion and CAPA implementation.
• Aid in customer complaint investigations and prepare summaries of findings.
• Communicate investigation status, risks, and key quality metrics to Quality leadership.
• Analyze investigation trends to identify systemic issues and recommend appropriate corrective actions.
• Build strong relationships with Operations, Manufacturing, Quality, and other business partners to facilitate efficient investigation and CAPA management.

Qualifications

• Education: B.S. degree, STEM preferred
• Experience: Experience in Quality Assurance within a regulated manufacturing environment. Preferred experience in one or more of the following industries: Pharmaceuticals, Medical Devices, Consumer Healthcare, OTC Products, Cosmetics, Food or Dietary Supplements.
• Required Skills: Experience supporting quality investigations and CAPA processes. Familiarity with quality systems, including Standard Operating Procedures (SOPs), Change Controls, Non-Conformance documentation, and Manufacturing Work Instructions. Strong analytical and problem-solving abilities. Ability to prioritize multiple assignments while meeting deadlines. Excellent written and verbal communication skills. Proven ability to collaborate across Quality, Manufacturing, and Operations teams. Comfortable working onsite in a fast-paced manufacturing environment.
• Preferred Qualifications: Plant Quality Assurance experience. Experience with investigation tracking, trending, and quality metrics reporting. Experience participating in quality review boards or cross-functional quality meetings.