Senior QC Investigator: Root-Cause & CAPA Leader

Acrotech Biopharma Inc; Durham (NC); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Medical and Rx Benefits

Dental Benefits

Vision Plan

401(k) Plan

Job summary

Acrotech Biopharma Inc. is seeking a QC Investigator to conduct scientific investigations of laboratory deviations, including OOS, OOT, and atypical results, ensuring alignment with FDA, MHRA, EU GMP and SOPs.

The role involves root-cause analysis, CAPA implementation, and timely closure of QAMS documents. Qualifications include 3–8 years in QC within pharma, with 2–3 years in OOS/OOT investigations; MDI experience is a plus.

Qualifications

• Excellent technical writing skills, communication skills, and organization skills.
• 3–8 years of experience in QC within the pharmaceutical industry.
• Minimum 2–3 years handling OOS/OOT investigations.
• MDI investigations experience preferred.

Responsibilities

• Lead and conduct investigations for OOS, OOT, atypical results, and laboratory incidents.
• Follow a structured investigation approach per site SOP.
• Write the investigation protocol and reports.
• Ensure timely closure of investigations within defined timelines.
• Define and recommend CAPA; track CAPA effectiveness and closure.
• Review analytical data, chromatograms, spectra, and raw data.

Skills

Technical writing

Communication

Organization

OOS/OOT investigations

Quality systems

Education

BS in pharmaceutical science/related field

MS or higher degree in related field

Job description

Acrotech Biopharma Inc. is seeking a QC Investigator to conduct scientific investigations of laboratory deviations, including OOS, OOT, and atypical results, ensuring alignment with FDA, MHRA, EU GMP and SOPs.

The role involves root-cause analysis, CAPA implementation, and timely closure of QAMS documents. Qualifications include 3–8 years in QC within pharma, with 2–3 years in OOS/OOT investigations; MDI experience is a plus.