Quality Assurance Investigator II, Product Complaints

Regulatory Toolkit; Greenville (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific in Greenville, NC seeks a QA Specialist II, Product Complaints to support investigations and resolution of product complaints in a regulated CDMO environment.

Under general supervision you will perform low-to-moderate complexity investigations, collect data, draft reports, and escalate issues while collaborating with Manufacturing, Quality Control, Supply Chain, and Regulatory teams.

Qualifications

• Bachelor's degree in health science, life science, engineering, or related discipline.
• 2–4 years of experience in pharmaceutical or biotechnology industry.
• Experience supporting GMP investigations (complaints, deviations, or quality events) preferred.

Responsibilities

• Perform product complaint investigations of low to moderate complexity in accordance with cGMPs, internal procedures, and quality systems.
• Collect, document, and assess relevant data to support root cause analysis and investigation conclusions.
• Draft investigation reports and supporting documentation for review and approval by senior Quality staff.
• Escalate potential quality, regulatory, or patient safety concerns to management in a timely manner.
• Support implementation and tracking of corrective and preventive actions (CAPA) as assigned.
• Collaborate with Manufacturing, Quality Control, Supply Chain, and other functions to gather information and support investigation activities.
• Assist with preparation for customer inquiries, audits, and regulatory inspections related to product complaints.
• Follow all safety, training, and compliance requirements to maintain an inspection-ready environment.
• Manage assigned workload to meet established timelines while maintaining accuracy and attention to detail.
• Perform other duties as assigned.

Skills

Communication

Organization

Multitasking

Learning mindset

Education

Bachelor's degree in health science or related field

Job description

Thermo Fisher Scientific in Greenville, NC seeks a QA Specialist II, Product Complaints to support investigations and resolution of product complaints in a regulated CDMO environment.

Under general supervision you will perform low-to-moderate complexity investigations, collect data, draft reports, and escalate issues while collaborating with Manufacturing, Quality Control, Supply Chain, and Regulatory teams.