Deviation Management Investigator I – GMP Manufacturing

Spectraforce Technologies Inc; West Point (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

Spectraforce Technologies Inc. is seeking a Deviations Management Specialist – I (Assistant) for our West Point, PA site. The role focuses on resolving process deviations, leading investigations, and driving CAPA programs to enhance manufacturing quality.

The position requires a background in engineering or science, 1–3 years in a cGMP setting, and strong writing and communication skills to collaborate across manufacturing and laboratory teams in aseptic environments.

Qualifications

• Bachelor’s or Master’s degree in engineering/science; required for the role.
• 1–3 years post‑Bachelor’s experience in a cGMP pharmaceutical/biotech setting; academics/internships accepted.
• Experience writing investigations with root cause analysis and CAPA for manufacturing deviations.
• Familiar with Lean Six Sigma and strong analytical/problem solving abilities.
• Ability to work independently and in cross‑functional teams; excellent writing and verbal skills.

Responsibilities

• Resolve deviations and develop/implement corrective/preventive actions; lead investigations.
• Provide on‑floor technical/scientific support for manufacturing areas.
• Develop working relationships with aseptic manufacturing, testing, planning and release teams; apply sound science/engineering principles.
• Troubleshoot and perform root cause analysis of lab test failures and atypical events; implement CAPAs.
• Analyze complex problems through critical thinking and design/execute lab or pilot scale experiments.

Skills

cGMP experience in pharma/biotech

Root cause analysis & CAPA development

Lean Six Sigma methodologies

Analytical/problem solving

Technical writing

Verbal communication skills

Cross-functional teamwork

Education

B.S./M.S. degree in appropriate engineering/scientific field

Job description

Spectraforce Technologies Inc. is seeking a Deviations Management Specialist – I (Assistant) for our West Point, PA site. The role focuses on resolving process deviations, leading investigations, and driving CAPA programs to enhance manufacturing quality.

The position requires a background in engineering or science, 1–3 years in a cGMP setting, and strong writing and communication skills to collaborate across manufacturing and laboratory teams in aseptic environments.