Pharma Validation Analyst – GMP Compliance & Quality

PCI Pharma Services; Rockford (IL); On-site; USD 27,000 - 31,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Job summary

PCI Pharma Services in Rockford, IL is seeking a Validation Analyst I to own validation projects with supervision. You will prepare protocols, statements, and reports for new customer launches and maintain validated processes across sites.

The role requires basic math and computer skills, attention to detail, and effective communication. Some overtime/weekend work may be required; a high school diploma or GED is required.

Qualifications

• High School Diploma or GED and/or 1-3 years related experience and/or training.
• Basic mathematical skills.
• Basic computer skills: ability to perform basic computer tasks and operate common programs.
• Minimum Professional Proficiency: ability to participate effectively in conversations and read standard items.
• Intermediate reasoning: ability to apply common sense to follow instructions and handle multiple variables.

Responsibilities

• Owns limited risk validation projects under supervision.
• Prepares validation protocols, statements, reports, and master validation plans for new launches and maintains existing validated processes.
• Ensures validation documentation completion and closure, coordinating multiple approvals.
• Prepares change control and validation history reports for audits.
• Communicates progress to Validation Supervisor/Manager and participates in meetings.
• Investigates deviations and documents corrective actions to close out projects.
• Acts as primary contact for quality validation activities and managing expectations.
• Interprets standards and specifications for dissemination to validation teams.
• Follows PCI, cGMP, GCP, GAMP, 21CFR, and Annex 11 policies.

Skills

Attention to detail

Problem solving

Communication skills

Teamwork

Education

High School Diploma or GED

Tools

Microsoft Office

Job description

PCI Pharma Services in Rockford, IL is seeking a Validation Analyst I to own validation projects with supervision. You will prepare protocols, statements, and reports for new customer launches and maintain validated processes across sites.

The role requires basic math and computer skills, attention to detail, and effective communication. Some overtime/weekend work may be required; a high school diploma or GED is required.