Senior QC Investigations & CAPA Lead

Job Description

Position: Senior Quality Control Investigator

Location: Boston, MA (Fully Onsite)

Schedule: Wednesday–Saturday, 9:00 AM – 7:30 PM

Duration: 12+ months

Key Responsibilities:

• Lead deviation investigations, CAPAs, change controls, and risk assessments for cell manufacturing in a GMP-regulated environment.
• Own the full lifecycle of quality records in eQMS, ensuring timelines and compliance are met.
• Triage manufacturing issues in real-time on the floor and coordinate with SMEs for immediate actions.
• Drive cross-functional root cause analysis meetings and propose corrective/preventive actions.
• Write and review technical investigations and promote compliance best practices across teams.

Requirements:

• 6+ years of progressive experience in pharmaceutical development and manufacturing.
• Bachelor’s degree in engineering, science, or related discipline.
• Strong QC background with OOS, deviation, and investigation experience.
• Proficient in GMP compliance and technical writing.
• Ability to gown for Grade B manufacturing environments.