Validation Analyst III - Quality & Compliance Lead

PCI Pharma Services; Rockford (IL); On-site; USD 38,000 - 42,000; Full time

Benefits offered by this job

Health insurance (dental & vision)

401(k) plan

Paid time off

Flexible spending account

Job summary

PCI Pharma Services is seeking a Validation Analyst III in Rockford, IL to manage large customer validation projects with minimal supervision. You will generate and execute validation protocols, assist in audits, and determine validation needs.

Responsibilities include preparing validation documentation, coordinating internal and customer approvals, and ensuring accuracy of validation history. Overtime/weekend work may be required.

Qualifications

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.
• College Level Mathematical Skills.
• Intermediate Computer Skills: ability to perform more complex computer tasks.
• Full Professional Proficiency: speak, read, and write fluently.
• High Reasoning: solve problems with limited standardization.

Responsibilities

• Performs validation activities to assure compliance with government and customer requirements.
• Prepares validation protocols, validation statements, and master validation plans for new launches and maintained processes.
• Ensures documentation completion and organizer approvals for validation packages.
• Prepares change control and validation history for customer audits.
• Attends conference calls and communicates project goals and progress.
• Investigates deviations and documents CAPA until resolution.

Skills

Mathematical skills

English proficiency

Reasoning

Time management

Computer skills

Education

Associate degree in a related field

Job description

PCI Pharma Services is seeking a Validation Analyst III in Rockford, IL to manage large customer validation projects with minimal supervision. You will generate and execute validation protocols, assist in audits, and determine validation needs.

Responsibilities include preparing validation documentation, coordinating internal and customer approvals, and ensuring accuracy of validation history. Overtime/weekend work may be required.