Process Quality Engineer - GMP & Continuous Improvement

The Ritedose Corporation; Columbia (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

The Ritedose Corporation in Columbia, SC is seeking a Process Quality Engineer to support QA monitoring of manufacturing processes, materials, utilities and environmental controls. You will lead deviation investigations, root cause analyses, product risk assessments, and CAPAs while ensuring GMP compliance and driving continuous improvement.

You will act as a technical expert for quality initiatives in areas such as Cleanrooms, BFS manufacturing, drug product formulations and pharmaceutical

Qualifications

• Four-year college degree in Engineering or Life Sciences.
• Proficiency with statistical analysis tools and software packages.
• Strong technical writing, documentation, and communication skills.
• Strong leadership and mentorship skills.
• Familiarity with AQL, Six Sigma, Kaizen, and other Quality Improvement tools.
• Experience in pharmaceutical/regulatory environments (GMP, ICH, FDA, EMA preferred).

Responsibilities

• Lead and execute deviation investigations, root cause analyses, product risk assessments, and corrective/preventive actions.
• Analyze manufacturing trends, unplanned maintenance, and environmental controls (HVAC) using statistical tools.
• Serve as technical expert for quality initiatives in Cleanrooms, BFS, Drug Product Formulation, and Packaging.
• Collaborate with Operations, Development, Compliance, and Validation to ensure GMP compliance.
• Support new process development, change management, and risk management.
• Create and revise department documents and coordinate equipment calibration.
• Support regulatory inspections, audits, and batch-related process quality inquiries.

Skills

Statistical analysis

Technical writing

Leadership

Six Sigma

Kaizen

Quality Improvement tools

Education

Engineering

Life Sciences

Job description

The Ritedose Corporation in Columbia, SC is seeking a Process Quality Engineer to support QA monitoring of manufacturing processes, materials, utilities and environmental controls. You will lead deviation investigations, root cause analyses, product risk assessments, and CAPAs while ensuring GMP compliance and driving continuous improvement.

You will act as a technical expert for quality initiatives in areas such as Cleanrooms, BFS manufacturing, drug product formulations and pharmaceutical