Process Quality Engineer

THE RITEDOSE CORPORATION • Columbia, SC

2d • Onsite

About The Position

The Process Quality Engineer supports Quality Assurance monitoring of manufacturing processes, materials, utilities, and related environmental controls within manufacturing operations. The role ensures compliance with GMP regulations, investigates deviations, and maintains product and process quality standards. It requires technical expertise and a commitment to continuous improvement in a regulated environment.

Requirements

• Four-year college degree in Engineering, Life Sciences, or a related field; a repeated qualification section specifies Engineering.
• Proficiency with statistical analysis tools and software packages.
• Strong technical writing, documentation, and communication skills.
• Strong leadership skills; one qualification section also specifies mentorship skills.
• Familiarity with AQL, Six Sigma, Kaizen, and/or other quality improvement tools.

Nice To Haves

• Experience in the pharmaceutical or regulatory environment.
• Knowledge of GMP, ICH, FDA, and EMA requirements.

Responsibilities

• Lead and execute deviation investigations, root cause analyses, product risk assessments, and corrective and preventive actions.
• Analyze manufacturing trends, unplanned maintenance, and environmental controls, including HVAC and related systems, using statistical tools to support a continuous state of quality.
• Serve as a technical expert for quality initiatives and continuous improvement in one or more areas: cleanroom facilities; drug product formulation (solutions and suspensions); Blow-Fill-Seal (BFS) manufacturing; or pharmaceutical packaging.
• Collaborate with Operations, Development, Compliance, and Validation teams to ensure processes comply with GMP and company standards.
• Support new process development, change management, and risk management.
• Create and revise department documents, such as procedures, and coordinate equipment calibration within the department.
• Support regulatory inspections, audits, and batch-related process quality inquiries.

What This Job Offers

• Job Type: Full-time