Lead QC Investigator - OOS/OOT & CAPA

Recipharm; Boston (MA); On-site; USD 110,000 - 115,000; Full time

Job summary

Recipharm is seeking a QC Investigator to lead and coordinate laboratory investigations related to OOS, OOT, atypical results, deviations, and other quality events within Quality Control, ensuring cGMP compliance and regulatory readiness.

You will partner with Quality Assurance, Manufacturing, Process Development, and Engineering to identify root causes, document conclusions, drive CAPAs, and advance continuous improvement within the Quality Management System.

Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related field required.
• Master’s Degree in a scientific discipline preferred.
• Training or certifications in Quality Systems, Root Cause Analysis, Lean Six Sigma, or Pharmaceutical Manufacturing are a plus.

Responsibilities

• Lead and coordinate investigations for OOS, OOT, atypical, invalid, and unexpected lab results.
• Oversee Phase I investigations and coordinate Phase II manufacturing/process investigations when required.
• Review data, notebooks, instrument data, chromatograms, calculations, and documentation for accuracy.

Skills

OOS/OOT investigations

Investigation leadership

cGMP/regulatory knowledge

CAPA & corrective actions

Data interpretation

Regulatory inspections support

eQMS/LIMS experience

Analytical method knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry or related field

Master’s degree preferred

Quality Systems / RCA / Lean Six Sigma training a plus

Tools

LIMS

Chromatography data systems

eQMS

Job description

Recipharm is seeking a QC Investigator to lead and coordinate laboratory investigations related to OOS, OOT, atypical results, deviations, and other quality events within Quality Control, ensuring cGMP compliance and regulatory readiness.

You will partner with Quality Assurance, Manufacturing, Process Development, and Engineering to identify root causes, document conclusions, drive CAPAs, and advance continuous improvement within the Quality Management System.