QC Lead Investigator, Lab Equipment

The Fountain Group is currently seeking a QC Lead Investigator, Lab Equipment for a prominent client of ours. This position is located in Philadelphia, PA. Details for the position are as follows:

• 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.

If you are interested in hearing more about the position, please respond to this posting with your resume attached.
Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.


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