GMP Manufacturing Associate, Documentation & CAPA Lead

Wwshemi; Philadelphia (Philadelphia County); On-site; USD 90,000 - 115,000; Full time

Job summary

Iovance Biotherapeutics is seeking a detail-oriented Documentation Specialist to support GMP manufacturing operations in Philadelphia. You will draft and revise SOPs, batch records, deviations and CAPAs, ensuring alignment with GDP and 21 CFR Part 11 requirements.

You will lead investigations of nonconformances, manage change controls, and coordinate with cross-functional teams to ensure compliant documentation and timely data reporting.

Qualifications

• Bachelor's degree in biology, biochemistry, bioengineering or related field.
• Minimum 2 years of GMP manufacturing experience.
• Strong knowledge of GMP, GDP, and 21 CFR Part 11.

Responsibilities

• Draft and approve SOPs, Batch Records, Deviations, CAPAs and reflect current procedures.
• Lead investigations into nonconformances and deviations with root-cause analysis.
• Own change controls for manufacturing areas and equipment.
• Support technology transfer and cross-functional communication for technical data.
• Coordinate front-end document requests with supporting departments.
• Ensure deviations and CAPAs are closed timely and Batch Records are updated.

Skills

GMP manufacturing

Quality systems

Documentation control

Root cause analysis

Troubleshooting

English proficiency

Education

Bachelor's degree in biology/biotech

Tools

LIMS

MS Office

Job description

Iovance Biotherapeutics is seeking a detail-oriented Documentation Specialist to support GMP manufacturing operations in Philadelphia. You will draft and revise SOPs, batch records, deviations and CAPAs, ensuring alignment with GDP and 21 CFR Part 11 requirements.

You will lead investigations of nonconformances, manage change controls, and coordinate with cross-functional teams to ensure compliant documentation and timely data reporting.