Complaint Investigator

Title : Complaint Investigator

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

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

Overview

We are seeking Complaint Investigators to join a growing parenteral manufacturing site in the Charlotte 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.

Must-Have Qualifications

a. 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.

o Compliance-first decision making

o Strong attention to detail and documentation (“if it isn’t documented, it didn’t happen”)

o Root cause and problem-solving orientation

o Integrity and independence, willing to escalate or challenge when needed

required. This could include complaint investigations or deviation investigations within a GMP

quality management system.

Preferred Skills

accuracy.