Complaint Investigator

Type: 12-month contract (with potential for extension or conversion)

Location: RTP, NC (on-site, Monday–Friday, 8:00am–5:00pm)

Start Date: mid to late October

Overview

We are seeking Complaint Investigators to join a growing parenteral manufacturing site in the Research Triangle Park area. This team ensures that product complaints are thoroughly investigated, documented, and closed in compliance with GMP and regulatory expectations. This role is critical to maintaining patient safety, product quality, and regulatory compliance.

Key Responsibilities

• Conduct investigations into product complaints (e.g., device malfunctions, product quality issues).
• Review manufacturing and quality data to determine potential root causes.
• Ensure investigations are documented thoroughly and closed within regulatory timelines.
• Collaborate with manufacturing, technical services, and other functions to gather information.
• Prepare investigation summaries and ensure appropriate checks and balances are in place to defend product quality.
• Contribute to continuous improvement of the complaint investigation process.

Must-Have Qualifications

• Quality mindset

1. Candidates should demonstrate a strong focus on compliance, documentation, and patient safety. This may come from previous roles in QA, QC, Operations, Engineering, MSAT/TSMS, or Lab functions, but the key is prioritizing quality over convenience.

• Compliance-first decision making
• Strong attention to detail and documentation (“if it isn’t documented, it didn’t happen”)
• Root cause and problem-solving orientation
• Integrity and independence, willing to escalate or challenge when needed
• Investigation experience – Prior experience in pharmaceutical manufacturing investigations is required. This could include complaint investigations or deviation investigations within a GMP quality management system.

Preferred Skills

• Familiarity with electronic quality management systems (Veeva or similar).
• Bachelor’s degree preferred (or equivalent industry experience).
• Strong analytical and writing skills; ability to manage multiple investigations with timeliness and accuracy.
• Inquisitive, detail-oriented, and able to work independently.