Senior In-Process Quality Engineer (cGMP & QA Systems)

Endo; Hobart (IN); On-site; USD 100,000 - 135,000; Full time

Job summary

Par Health is seeking a Quality Assurance subject matter expert to lead quality systems and ensure cGMP compliance across manufacturing lines. You will drive CAPA and change control, oversee investigations, and mentor teams to prevent quality issues.

The role requires a minimum 5 years in pharma manufacturing, strong knowledge of Quality Systems, and the ability to support regulatory submissions and audits. Travel is expected.

Qualifications

• Bachelor degree preferred in engineering or related pharma field.
• Minimum 5 years in a pharmaceutical manufacturing environment (QA/QC or engineering).
• Familiarity with Quality Systems and cGMPs for Finished Dosage Products.

Responsibilities

• Manage and improve Quality Systems; update SOPs for cGMP compliance; oversee Change Control and CAPA processes.
• Lead investigations, root cause analyses, and risk assessments; review reports for detail and CAPA adequacy.
• Support regulatory activities (NDA/ANDA submissions) and internal/external audits and readiness.

Skills

Strong verbal and written comms

Knowledge of Quality Systems

Knowledge of cGMPs

Statistics & validation basics

Issue identification & resolution

Leadership & communication

MS Office, Minitab, databases

Education

Bachelor's degree in engineering or related pharma field

Associates degree with equivalent experience

Job description

Par Health is seeking a Quality Assurance subject matter expert to lead quality systems and ensure cGMP compliance across manufacturing lines. You will drive CAPA and change control, oversee investigations, and mentor teams to prevent quality issues.

The role requires a minimum 5 years in pharma manufacturing, strong knowledge of Quality Systems, and the ability to support regulatory submissions and audits. Travel is expected.