QC Investigator — Root-Cause & CAPA Analyst (Pharma)

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision plan

401(k) Plan

Employee Assistance Program (EAP)

Job summary

Aurolife is seeking a QC Investigator to conduct thorough investigations into laboratory deviations, ensuring compliance with FDA, MHRA and EU GMP standards. The role requires strong technical writing and report writing abilities, with experience in CAPA and QAMS documentation.

The position covers handling OOS/OOT investigations, writing protocols, and ensuring timely closure of investigations under defined timelines, with opportunities to contribute to continuous quality improvement in a

Qualifications

• 3-8 years of QC experience in the pharmaceutical industry.
• Minimum 2-3 years handling OOS/OOT investigations.
• MDI investigations experience preferred.
• Strong technical writing, communication, and organizational skills.

Responsibilities

• Lead and conduct investigations for OOS, OOT, atypical results, and laboratory incidents.
• Follow site SOPs and write investigation protocols and reports.
• Ensure timely closure of investigations within defined timelines.
• Define and recommend CAPA and track effectiveness.
• Maintain QAMS documents and GPL in the laboratory.
• Review analytical data, chromatograms, spectra and raw data; identify issues.
• Support method troubleshooting and improvements.
• Additional duties as assigned by Director QC.

Skills

Technical writing

Communication

Organization

Education

BS or MS in pharma/regulated field

MS or higher with QC focus

Job description

Aurolife is seeking a QC Investigator to conduct thorough investigations into laboratory deviations, ensuring compliance with FDA, MHRA and EU GMP standards. The role requires strong technical writing and report writing abilities, with experience in CAPA and QAMS documentation.

The position covers handling OOS/OOT investigations, writing protocols, and ensuring timely closure of investigations under defined timelines, with opportunities to contribute to continuous quality improvement in a