QC Lead Investigator/Event Owner (Laboratory Equipment)

Dawar Consulting • Philadelphia, PA

6d • $46

About The Position

The Quality Control (QC) team is seeking a Laboratory Equipment Investigation Lead responsible for managing investigations, deviations, change controls, and CAPAs related to QC laboratory equipment and systems. The role ensures compliance with cGMP regulations and internal quality procedures, while supporting QC operations and regulatory readiness.

Requirements

• Bachelor’s degree in Science, Engineering, Quality, or related field (or equivalent experience).
• Experience in QC, QA, or regulated biotech/pharmaceutical environments
• Knowledge of cGMP, FDA regulations, and quality systems
• Strong analytical, documentation, and cross -functional collaboration skills.

Nice To Haves

• Familiarity with laboratory systems such as Empower, LabX, SoftMax, qPCR, or similar preferred.
• Experience with Veeva Vault QMS and root cause analysis methods (5 Whys, Fishbone, FMEA) preferred.

Responsibilities

• Conduct and manage QC laboratory equipment investigations, deviations, and quality incidents
• Identify root causes and implement Corrective and Preventive Actions (CAPAs)
• Author and manage change controls for laboratory equipment, systems, and software.
• Serve as system administrator for QC laboratory systems (user access, templates, method controls).
• Collaborate with QC, Lab Systems Engineering, QA, IT, and cross -functional teams
• Perform risk and impact assessments for QC operations.
• Support regulatory inspections and audits
• Maintain cGMP documentation and update SOPs and supporting documents as required.

Benefits

• Medical
• Dental
• Vision
• Paid Sick leave
• 401K

What This Job Offers

• Career Level: Mid Level