Senior QA Engineer - Inspection & Packaging Lead

incog; Fishers (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

INCOG BioPharma Services is seeking a QA Senior Engineer in Fishers, IN to lead inspection, labeling, packaging, and serialization quality systems for aseptically filled products. You will work with Manufacturing, Engineering, and Technical Services to ensure state-of-the-art inspection readiness and regulatory compliance.

The role requires deep GMP knowledge, FDA/EMA experience, and a hands-on leader for deviations, CAPA, and change controls in a fast-paced CDMO environment.

Qualifications

• Bachelor’s or higher in a scientific, engineering, or technical discipline.
• 5+ years in pharmaceutical QA with finished product inspection/packaging/serialization.
• Deep knowledge of FDA 21 CFR Parts 210, 211 and DSCSA serialization requirements.
• Experience supporting client/regulatory audits and CAPA lifecycle.

Responsibilities

• Oversee and improve quality systems for visual inspection of aseptically filled products.
• Own labeling, packaging, and serialization quality programs; ensure regulatory compliance.
• Lead investigations, root causes, and CAPA related to inspection defects and packaging.
• Collaborate with Manufacturing, Engineering, and Technical Services on qualifications and changes.
• Prepare audit-ready documentation and support regulatory inspections as SME.

Skills

QA Oversight

Inspection Methods

Serialization

SOPs & Documentation

CAPA & Deviation

GMP & Regulatory Knowledge

FDA/EMA Experience

Education

Bachelor’s degree in Science/Engineering

Job description

INCOG BioPharma Services is seeking a QA Senior Engineer in Fishers, IN to lead inspection, labeling, packaging, and serialization quality systems for aseptically filled products. You will work with Manufacturing, Engineering, and Technical Services to ensure state-of-the-art inspection readiness and regulatory compliance.

The role requires deep GMP knowledge, FDA/EMA experience, and a hands-on leader for deviations, CAPA, and change controls in a fast-paced CDMO environment.