Pharma QA Complaints Lead: cGMP & CAPA Expert

United Pharma Technologies Inc; New York (NY); On-site; USD 90,000 - 125,000; Full time

Job summary

United Pharma Technologies Inc is seeking an experienced QA Complaints Specialist to manage the full lifecycle of product quality complaints in a cGMP environment. You will coordinate investigations, review data across QA, Manufacturing, and Regulatory, and ensure timely closure with robust documentation.

The role requires 5+ years in pharmaceutical quality environments, strong analytical and cross-functional collaboration skills, and proficiency with common eQMS tools and regulatory

Qualifications

• Bachelor's degree in a scientific discipline relevant to pharma quality.
• 5+ years in Quality Assurance or product complaints in pharma/biopharma.
• Hands-on experience with complaint investigations and GMP/GDP quality systems.
• Understanding of deviations, investigations, CAPA, change control, and root-cause analysis.

Responsibilities

• Manage the full lifecycle of quality complaints from intake to closure.
• Review complaints for completeness and potential patient impact.
• Coordinate and conduct investigations, reviewing manufacturing and QA data.
• Assess regulatory reportability and escalation needs.
• Prepare clear investigation reports and maintain documentation within SOPs.
• Support CAPA activities and trend monitoring with quality metrics.

Skills

Quality assurance

Complaint investigations

cGMP/GMP

CAPA

Root cause analysis

Regulatory reporting

Documentation

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Biotechnology, Life Sciences, Engineering, or related scientific discipline

Tools

TrackWise

Veeva Quality

MasterControl

Sparta

Job description

United Pharma Technologies Inc is seeking an experienced QA Complaints Specialist to manage the full lifecycle of product quality complaints in a cGMP environment. You will coordinate investigations, review data across QA, Manufacturing, and Regulatory, and ensure timely closure with robust documentation.

The role requires 5+ years in pharmaceutical quality environments, strong analytical and cross-functional collaboration skills, and proficiency with common eQMS tools and regulatory