Investigator Jobs

About The Position

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