QC Lead Investigator/Event Owner

• Pay: $34-44.82/hr.
• 12-month assignment with possibility for extension or conversion based on performance and budget.

Responsibilities: 

• Conducted comprehensive laboratory equipment investigations, deviations, and quality incident reviews in accordance with cGMP, FDA regulations, and internal SOPs.
• Performed root cause analysis using tools such as 5 Whys, Fishbone diagrams, and FMEA, and implemented Corrective and Preventive Actions (CAPAs) to resolve quality events.
• Authored and managed change controls for the implementation and modification of QC laboratory equipment, systems, and software.
• Collaborated cross-functionally with Quality Control, Quality Assurance, Lab Systems Engineers, IT, and GxP Systems teams to investigate equipment issues and ensure timely resolution of deviations.
• Served as system administrator for QC laboratory equipment systems, performing activities such as user account management, method locking, template creation, and system configuration.
• Utilized laboratory systems and analytical software including Empower, LabX, SoftMax, Qx Manager, and qPCR platforms for QC operations and data review.
• Performed risk and impact assessments related to QC operations, equipment performance, and system changes.
• Supported regulatory inspections and audits, providing documentation and investigation records to demonstrate GMP compliance.
• Maintained Good Documentation Practices (GDP) while authoring investigation reports, CAPA records, SOP updates, and supporting documentation.
• Updated and maintained SOPs, protocols, and quality documents related to QC laboratory equipment and systems.

Qualifications:

• Bachelor’s degree in a scientific field with 3–5+ years or Master’s degree with 2+ years of experience in QC, QA, or analytical laboratories within a GMP-regulated manufacturing environment.
• Strong knowledge of FDA, ISO, and cGMP regulations and experience supporting compliant laboratory operations.
• Experience performing laboratory equipment investigations and deviation writing, including troubleshooting issues with analytical instruments (e.g., chromatography systems, PCR, immunoassay equipment).
• Proven experience with CAPA identification and implementation, root cause analysis (5 Whys, Fishbone, FMEA), and change control management.
• Familiarity with laboratory equipment software and data systems such as Empower, LabX, Qx Manager, SoftMax Pro, or similar platforms.
• Strong technical writing and documentation skills, including SOP updates, investigation reports, and quality records in systems such as Veeva Vault QMS.