Quality Specialist - Investigations & CAPA (Contract)

Quality Specialist - Investigations & CAPA (Contract)

Location: Lititz, PA (Onsite)

Employment Type: Contract

Position Summary

Our client, a global leader in the consumer healthcare industry, is seeking a Quality Specialist - Investigations & CAPA to support site Quality Operations. This role is responsible for coordinating, monitoring, and driving investigation and Corrective and Preventive Action (CAPA) activities to ensure compliance, timely execution, and continuous process improvement.

The ideal candidate has experience working in a regulated manufacturing environment and possesses strong organizational, analytical, and communication skills. This is an excellent opportunity to join a high-performing Quality team supporting well-established consumer health products.

Key Responsibilities

• Monitor the site investigation and CAPA process to ensure timely completion and compliance with established quality procedures.
• Coordinate 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.
• Assist with 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

• 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.

Why Apply?

This is an opportunity to join a respected, industry-leading organization where you''ll play a critical role in supporting product quality, regulatory compliance, and continuous improvement initiatives. The position offers exposure to cross-functional teams, meaningful quality systems work, and the chance to make an immediate impact within a collaborative manufacturing environment.

Application Period: This position opens for applications on 7/9/2026 and will remain open for a minimum of 30 days from the posting date.

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