QC Investigator

Client: Pharmaceutical company
Job Title: QC Investigator
Location: Durham, NC
Duration: Fulltime Perm role.

The QC Investigator is responsible for conducting thorough, scientific, and compliant investigations of laboratory-related deviations, including OOS (Out of Specification), OOT (Out of Trend), atypical results, and laboratory incidents. The role ensures investigations are performed in alignment with regulatory requirements (FDA, MHRA, EU GMP) and internal SOPs to determine root causes, assess impact, and implement effective CAPA.

• Lead and conduct investigations for:
• OOS (Out of Specification) results
• OOT (Out of Trend) results
• Atypical/aberrant results
• Laboratory incidents and deviations
• Follow a structured investigation approach as per site SOP.
• Writing the investigation Protocol and reports.
• Ensure timely closure of investigations within defined timelines.
• Define and recommend Corrective and Preventive Actions (CAPA).
• Track CAPA effectiveness and ensure timely closure.
• Responsible for closure of all QAMS documents on time
• Responsible for maintain GPL in laboratory
• Management of Standards / Column /Chemical in laboratory
• Review analytical data, chromatograms, spectra, and raw data.
• Identify analytical errors, instrument failures, or method-related issues.
• Support method troubleshooting and improvement.
• Other responsibilities assigned by Director QC on routine basis

Requirement:

• Excellent technical writing skills, communication skills, organization skills.
• 3-8 years of experience in QC within pharmaceutical industry.
• Minimum 2-3 years in handling OOS/OOT investigations.
• MDI investigations experience preferred.
• For BS, up to 5 years in a regulated pharmaceutical industry preferably in QC.
• For MS or higher degree, up to 3 years in a regulated pharmaceutical industry preferably in QC.
• Must be proficient with pharmaceutical drug manufacturing processes, cGMPs and other regulatory requirements.
• Experience in conducting, writing non-conformance investigations, root cause analyses, and identifying corrective actions.
• Experience in CAPA resolution and review of change Controls, SOPs, protocols/reports and quality indicator review.