Quality Manager III - Pharma GMP/GxP CAPA Lead

The Fountain Group; Swiftwater (Monroe County); On-site; USD 124,000 - 134,000; Full time

Benefits offered by this job

Referral Bonus

Job summary

The Fountain Group is seeking a Quality Manager for a one-year assignment in Swiftwater, PA. You will ensure pharmaceutical manufacturing processes, equipment, facilities, and documentation meet FDA, GMP, GxP, QSR, and internal quality standards. Daily work includes leading investigations and CAPA activities to prevent issues.

This is a day-shift, on-site role. Requirements: Bachelor's in Engineering or Life Sciences (Master's preferred) and 6–9 years in regulated environments with CAPA and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline required; Master's degree preferred.
• 6-9 years of experience in pharmaceutical, biopharmaceutical, or highly regulated manufacturing environments.
• Strong background in quality validation, quality systems, and regulatory compliance within life sciences.

Responsibilities

• Ensure pharmaceutical manufacturing processes, equipment, facilities, and documentation meet FDA, GMP, GxP, QSR, and internal quality requirements.
• Lead quality investigations, perform root cause and risk assessments, develop and implement CAPA plans, and monitor corrective actions to prevent recurring quality issues.

Skills

CAPA investigations

Root cause analysis

Regulatory compliance (QSR, GxP)

Quality systems

Documentation review

Education

Bachelor's degree in Engineering/Life Sciences or related

Master's degree preferred

Job description

The Fountain Group is seeking a Quality Manager for a one-year assignment in Swiftwater, PA. You will ensure pharmaceutical manufacturing processes, equipment, facilities, and documentation meet FDA, GMP, GxP, QSR, and internal quality standards. Daily work includes leading investigations and CAPA activities to prevent issues.

This is a day-shift, on-site role. Requirements: Bachelor's in Engineering or Life Sciences (Master's preferred) and 6–9 years in regulated environments with CAPA and