Quality Systems Engineer: CAPA & Investigations Lead

Contract Pharmacal Corp.; Hauppauge, Northern (NY, KY); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Contract Pharmacal Corp. is seeking a Quality Systems Engineer in Hauppauge, NY to lead quality event investigations, write protocols for reworks and reprocessing, and drive risk assessments and CAPAs.

The role requires strong analytical thinking, engineering background, and solid knowledge of cGMP and regulatory expectations. You will partner with Manufacturing, Quality, and Technical Operations to ensure inspection readiness and continuous improvement in quality systems.

Qualifications

• Lead quality event investigations (deviations, complaints, non-conformances, OOS).
• Develop protocols for reworks and reprocessing.
• Perform risk assessments and CAPAs with root cause analysis.

Responsibilities

• Lead and author complex quality event investigations and CAPAs.
• Apply structured problem-solving methodologies for robust conclusions.
• Ensure documentation meets regulatory standards (cGMP, FDA, EMA).
• Review investigation content from cross-functional teams for quality and consistency.
• Drive robust CAPAs addressing true root causes and sustainment.

Skills

Quality event investigations

CAPA development

Risk assessments

Data analysis

Root cause analysis

Technical writing

cGMP/FDA knowledge

Cross-functional collaboration

Excel/ data visualization

Quality systems

Education

Bachelor’s degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences

Tools

Minitab

Excel

Job description

Contract Pharmacal Corp. is seeking a Quality Systems Engineer in Hauppauge, NY to lead quality event investigations, write protocols for reworks and reprocessing, and drive risk assessments and CAPAs.

The role requires strong analytical thinking, engineering background, and solid knowledge of cGMP and regulatory expectations. You will partner with Manufacturing, Quality, and Technical Operations to ensure inspection readiness and continuous improvement in quality systems.