Quality Systems Engineer - Investigations & CAPAs

Contract Pharmacal Corp; Hauppauge (NY); On-site; USD 80,000 - 110,000; Full time

Job summary

Contract Pharmacal Corp in Hauppauge, NY is seeking a Quality Systems Engineer to lead quality event investigations, CAPA development, and risk assessments within a GMP-regulated environment. You will ensure inspection-ready documentation and drive continuous improvement across QA processes.

The role requires 5+ years in pharmaceutical QA/QE, with Six Sigma/RCA/PM/cGMP certifications preferred. Work hours are M-F, 8:00 AM–4:00 PM, with a pay range of $80,000–$110,000 per year depending on

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related technical discipline.
• 5+ years of experience in Quality Assurance or Quality Engineering within a pharmaceutical, biotech, or regulated manufacturing environment.
• Certifications for Six Sigma, Root Cause Analysis, Project Management, Technical Writing, cGMP, advanced data analysis preferred.
• Demonstrated experience leading quality event investigations, protocol writing, risk assessments and CAPAs.

Responsibilities

• Lead and author complex quality event investigations (deviations, complaints, non-conformances, and OOS), protocols (reworks and reprocessing), risk assessments and CAPAs.
• Apply structured problem-solving methodologies (e.g., lean and six-sigma, DMAIC, root cause analysis, FMEA, fishbone, 5-Why) to drive high-quality, defensible conclusions.
• Ensure all documentation meets cGMP, FDA, EMA, and internal quality standards, with a focus on clarity, logic, and inspection-ready narratives.
• Review and challenge investigation content prepared by cross-functional teams to elevate overall quality and consistency.
• Drive the development of robust, risk-based CAPAs that address true root causes rather than symptoms.
• Assess CAPA effectiveness and sustainability; identify trends and opportunities for system-level improvements.
• Partner with functional owners to ensure timely implementation and closure of quality actions.
• Analyze trends across quality vents to identify systemic risks, recurring failure modes, and opportunities for process improvement.
• Support continuous improvement initiatives by translating quality data into actionable insights.
• Contribute to the design or enhancement of quality processes, templates, and tools to improve investigation quality and efficiency.
• Serve as a thought partner to operations and technical teams during issue resolution and change management activities.
• Act as a trusted QA partner to Manufacturing, Packaging, Engineering, Technical Operations, Accounts Management, and Supply Chain.
• Provide risk-based quality input to support sound business decisions while maintaining regulatory compliance.
• Support inspection readiness activities, including responses to regulatory questions related to investigations and CAPAs.
• Complete internal audits and support external audits of CPC operations.
• Mentor junior QA staff or investigators by modeling high-quality investigation practices.
• Other responsibilities as assigned by Senior Management.

Skills

Quality investigations

CAPA development

cGMP knowledge

Risk assessment

Documentation writing

Data analysis (Minitab, Excel)

Auditing

Education

Bachelor’s in Engineering/Scientific field

5+ years QA/QE in pharma

Six Sigma/RCA/PM/cGMP certifications

Tools

Minitab

Excel

ERP/QMS systems

Job description

Contract Pharmacal Corp in Hauppauge, NY is seeking a Quality Systems Engineer to lead quality event investigations, CAPA development, and risk assessments within a GMP-regulated environment. You will ensure inspection-ready documentation and drive continuous improvement across QA processes.

The role requires 5+ years in pharmaceutical QA/QE, with Six Sigma/RCA/PM/cGMP certifications preferred. Work hours are M-F, 8:00 AM–4:00 PM, with a pay range of $80,000–$110,000 per year depending on