Senior QA Engineer: Inspection, Labeling & Packaging

INCOG BioPharma Services; Fishers (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

INCOG BioPharma Services seeks a QA Senior Engineer of Inspection, Labeling, and Packaging to oversee quality systems for aseptically filled products, labeling, packaging, and serialization. You will ensure regulatory compliance with FDA/EMA standards and support ISO guidance within a fast-paced CDMO environment.

Reporting to the QA Director of Quality Systems, the role emphasizes development and maintenance of inspection parameters, CAPA, and audit readiness across multiple products and client

Qualifications

• Experience in finished product inspection for aseptically filled vials, syringes, and cartridges.
• Knowledge of labeling, packaging, and serialization requirements per FDA/EMA.
• Experience with Deviation investigations and CAPA lifecycle.
• Proven ability to author and review SOPs and batch record sections.
• Experience with regulatory audits (FDA/EMA) and client audits.

Responsibilities

• Provide quality oversight for finished product visual inspection operations.
• Own and manage quality systems related to labeling, packaging, and serialization.
• Lead or support deviation investigations and CAPA activities.
• Collaborate with Manufacturing, Engineering, and Technical Services on inspection parameters.
• Ensure audit readiness for FDA, EMA, and client audits.
• Oversee process validation for inspection equipment and packaging lines.
• Review change controls, risk assessments, and validation protocols.

Skills

Quality oversight

Root cause analysis

CAPA lifecycle

Deviation investigations

Change controls

Risk assessments

Audit readiness

Validation protocols

Education

Bachelor's degree in science/engineering

Job description

INCOG BioPharma Services seeks a QA Senior Engineer of Inspection, Labeling, and Packaging to oversee quality systems for aseptically filled products, labeling, packaging, and serialization. You will ensure regulatory compliance with FDA/EMA standards and support ISO guidance within a fast-paced CDMO environment.

Reporting to the QA Director of Quality Systems, the role emphasizes development and maintenance of inspection parameters, CAPA, and audit readiness across multiple products and client