Quality Engineering Specialist — GMP Packaging & Materials

ARx Pharma; Glen Rock (York County); On-site; USD 85,000 - 110,000; Full time

Job summary

ARx Pharma is seeking a Quality Engineering Support Specialist to provide quality engineering support to raw material and supplier qualification activities and to ensure packaging and manufacturing operations meet regulatory standards.

The role collaborates with Planning, QA, and cross-functional teams to drive root-cause investigations, change controls, SOP development, and continuous improvement across GMP environments.

Qualifications

• Bachelor’s degree in Engineering (Chemical preferred) or other technical discipline with relevant expertise.
• 2+ years of experience in pharmaceutical manufacturing, quality, engineering, or regulated cGMP environment.
• Training/experience in cGMP and FDA protocols, cleaning/ process validation; experience with design control, DOE, QBD, PAT, risk analysis, LEAN manufacturing.

Responsibilities

• Provide quality engineering support for raw material qualification and supplier qualification processes.
• Lead or support AQL inspections and defect classification.
• Assist in developing and revising SOPs, specifications, forms, and controlled documents.
• Coordinate quality sampling and in-process inspection during GMP packaging production.
• Support supplier scorecards and supplier corrective actions (SCARs).
• Participate in change control activities and deviation investigations.
• Ensure activities comply with GMP requirements and company policies.

Skills

Attention to detail

Strong communication

Problem-solving

Risk-based decision making

Education

Bachelor's degree in Engineering (Chemical preferred) or related field

Tools

Excel

Word

PowerPoint

Outlook

Statistical software

DOE knowledge

Job description

ARx Pharma is seeking a Quality Engineering Support Specialist to provide quality engineering support to raw material and supplier qualification activities and to ensure packaging and manufacturing operations meet regulatory standards.

The role collaborates with Planning, QA, and cross-functional teams to drive root-cause investigations, change controls, SOP development, and continuous improvement across GMP environments.