QA Engineer - Drug Substance Validation & Compliance

Olon USA LLC; Concord Township (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

Olon USA LLC is seeking a Quality Engineer to drive QA oversight for Drug Substance Manufacturing processes from development through commercial release. The role involves acting as a Subject Matter Expert on DSM documents, assessing change impacts, and ensuring validation throughout startup to operations.

You will coordinate with global teams and support regulatory inspections in a cGMP environment. The position requires strong communication, problem-solving, and data integrity knowledge, with a

Qualifications

• Bachelor's degree in Chemical Engineering or related field.
• 3+ years of relevant chemical processing experience preferred.
• 3+ years GMP experience in a regulated environment.

Responsibilities

• Acts as Subject Matter Expert within QA for DSM program documents and processes.
• Oversees system modifications and change management to keep Manufacturing Systems validated.
• Reviews and approves lifecycle documents: risk assessments, specs, validation plans and reports.
• Generates and approves QA documentation for validation approaches and lifecycle.
• Supports manufacturing operations QA during start-up and commercial operation.
• Ensures quality objectives are met within deadlines and coordinates with global sites.
• Participates in optimization initiatives and regulatory inspections.
• Delivers quality meetings and reviews batch records.

Job description

Olon USA LLC is seeking a Quality Engineer to drive QA oversight for Drug Substance Manufacturing processes from development through commercial release. The role involves acting as a Subject Matter Expert on DSM documents, assessing change impacts, and ensuring validation throughout startup to operations.

You will coordinate with global teams and support regulatory inspections in a cGMP environment. The position requires strong communication, problem-solving, and data integrity knowledge, with a