JOB TITLE: QC Investigator
DEPARTMENT: Quality Control
REPORTS TO: Quality Control Management
EMPLOYEE STATUS: Exempt
LOCATION: Onsite Only – Monday-Friday
WORK AVAILABLE: Full-Time
SUMMARY:
The QC Investigator plays a critical quality assurance role within Quality Control in an FDA-regulated pharmaceutical environment. This position is directly responsible for leading, managing, and executing technical investigations related to Quality Control deviations, Out-of-Specification (OOS) findings, and non-conformances. The QC Investigator ensures the on-time initiation, thorough root cause analysis, and timely closure of quality records, while authoring Corrective and Preventive Action (CAPA) plans and evaluating their effectiveness. Additionally, this role monitors QC quality metrics, tracks adverse compliance trends, and authors monthly and annual compliance reports to drive continuous improvement.
DUTIES & RESPONSIBILITIES
Investigation Execution & Root Cause Analysis
- Lead and manage the end-to-end investigation lifecycle for QC deviations, Out-of-Specification (OOS) findings, Out-of-Trend (OOT) results, and laboratory events.
- Ensure on-time opening and logging of quality records following event identification, maintaining strict compliance with operational timelines.
- Collaborate closely with laboratory Subject Matter Experts (SMEs), analysts, Quality Assurance, and technical operations to perform thorough root cause analyses using structured tools (e.g., 5 Whys, Fishbone, FMEA).
- Drive timely investigation completion and ensure quality records are closed within established regulatory and internal standard operating procedure (SOP) timeframes.
CAPA Management & Effectiveness Checks
- Design, author, and implement targeted CAPAs to address identified root causes and prevent recurrence of quality events.
- Define clear, measurable criteria for Effectiveness Checks (ECs) and perform timely evaluations to ensure CAPAs permanently resolve systemic issues.
- Coordinate cross-functionally to assign and monitor CAPA action items across Quality Control, Quality Assurance, and site operations.
Compliance Monitoring, Trending & Technical Support
- Monitor and analyze QC deviation, OOS, and CAPA metrics continuously to identify adverse trends, systemic weaknesses, or emerging quality risks.
- Generate and present comprehensive monthly and annual QC compliance reports, highlighting key performance indicators (KPIs), open record status, and remediation progress.
- Support regulatory inspections (e.g., FDA) and internal audits as the designated SME for QC investigations, deviations, and CAPA programs.
- Utilize Quality Management Systems (QMS), Enterprise platforms, and data tracking tools to maintain accurate investigation records and metric dashboards.
REQUIRED QUALIFICATIONS
- Bachelor’s degree in Chemistry, Biology, Life Sciences, or a related scientific/technical discipline.
- 2 - 4 years of relevant Quality Control or technical writing/investigation experience in an FDA-regulated cGMP environment.
- Direct hands-on experience managing and authoring technical deviations, OOS investigations, CAPAs, and effectiveness checks within a cGMP environment.
- Strong working knowledge of cGMP regulations, FDA guidelines, root cause methodology, and standard laboratory documentation practices.
- Demonstrated ability to manage multiple quality records simultaneously, meet tight compliance deadlines, and drive timely closures.
- High attention to detail, strong technical writing skills, and effective cross-functional communication abilities.
PRFERRED EXPERIENCE
- Proven experience utilizing formal Root Cause Analysis (RCA) tools in an analytical testing laboratory setting.
- Proficiency with Electronic Quality Management Systems (eQMS) such as TrackWise, Veeva Vault, or Master Control, along with data management platforms like LIMS or Excel.
- Prior experience interfacing with regulatory auditors (e.g., FDA) to present technical investigation reports.
- Experience developing and presenting technical quality metrics and trending dashboards to management.
KEY COMPETENCIES
- Technical writing and structured investigation methodology (RCA, OOS, Deviation management)
- Timely execution and track record of on-time quality record closures
- CAPA design, implementation, and effectiveness monitoring
- Data collection, adverse trend analysis, and monthly/annual compliance reporting
- Cross-functional collaboration and SME interviewing techniques
- Strict compliance mindset and deep knowledge of cGMP standard