Clinical Quality Operations Lead

PCI Pharma Services; Rockford (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services seeks a Clinical Quality Supervisor to oversee day-to-day operations of the Clinical Quality Department, including In-Process/FG inspections and occasional Receiving Inspections. You will resolve quality deviations, train staff, and uphold GMP-compliant standards aligned with SOPs and customer requirements.

The role emphasizes leading Quality Ops, issuing Root Cause/Corrective Actions, and coordinating with Operations to balance quality with productivity.

Qualifications

• Associate's Degree in a related field or 1-3 years related experience/training.
• Basic Mathematical Skills.
• Ability to perform more complex computer tasks.
• Full Professional Proficiency: speak, read, write fluently.
• Strong reasoning to define problems and draw valid conclusions.
• High standard of report writing.

Responsibilities

• Supervise In-Process/FG Inspection, Distribution and Returns Inspection, and Clinical Quality Label Room Inspection teams.
• Coach quality inspectors to achieve high performance goals and PCI standards.
• Oversee quality improvement processes and training for direct reports.
• Resolve quality issues using SOPs and provide risk-based decisions.
• Prepare and present Quality Ops metrics to management and teams.
• Review customer standards, procedures, specs, and batch records.
• Ensure Right First Time documentation across functional areas and discuss preventive actions.
• Coordinate with QA and Ops to maintain quality and business alignment.
• Standardize departmental work practices to improve quality and ensure compliance.

Skills

Basic Math

Intermediate Computer Skills

Professional Proficiency

High Reasoning

Mathematical Reasoning

Report Writing

Problem Solving

Education

Associate's Degree in a related field

1-3 years related experience

Job description

PCI Pharma Services seeks a Clinical Quality Supervisor to oversee day-to-day operations of the Clinical Quality Department, including In-Process/FG inspections and occasional Receiving Inspections. You will resolve quality deviations, train staff, and uphold GMP-compliant standards aligned with SOPs and customer requirements.

The role emphasizes leading Quality Ops, issuing Root Cause/Corrective Actions, and coordinating with Operations to balance quality with productivity.