Microbiology Quality & CAPA Investigator

Nephron Pharmaceuticals Corp; Columbia (SC); On-site; USD 65,000 - 85,000; Full time

Job summary

Nephron Pharmaceuticals Corp. in United States, South Carolina, Columbia seeks a Microbiology Quality Investigator to ensure FDA compliance in microbiology investigations. You will handle CAPAs, deviations, memorandums and prepare data for tracking and reporting while coordinating cross-functionally.

The role emphasizes training, document control, and adherence to SOPs, with a focus on timely completion of investigations and strong collaboration with QA leadership.

Qualifications

• Bachelor’s degree preferred with 1–2 years of pharmaceutical quality or microbiology experience.
• 1–3 years of experience with MS Word, Excel, and PowerPoint.
• Pharmaceutical technical writing experience is preferred.
• Knowledge of cGMP and FDA regulations applicable to microbiology.
• Familiar with document control procedures and standards.
• Strong writing, organization, and multitasking abilities.

Responsibilities

• Effectively complete microbiology excursion reports and related documentation on time.
• Execute CAPAs, QE, memorandums, and deviations for the Microbiology program.
• Coordinate with Microbiology and other departments for training on investigations.
• Understand USP, FDA, and compendial standards and apply them.
• Prepare reports for EM tracking, trending, and CAPA outcomes.
• Update and maintain investigation logs for visibility.
• Ensure oversight of CAPA plans and investigation results.
• Maintain SOP adherence and complete SOP revisions.
• Communicate observations to management and leadership teams.

Skills

cGMP knowledge

FDA regulations

Technical writing

Root Cause Analysis

Project management

Communication

Time management

Analytical thinking

Education

Bachelor’s degree

Tools

MS Word

MS Excel

MS PowerPoint

SharePoint

TrackWise

Job description

Nephron Pharmaceuticals Corp. in United States, South Carolina, Columbia seeks a Microbiology Quality Investigator to ensure FDA compliance in microbiology investigations. You will handle CAPAs, deviations, memorandums and prepare data for tracking and reporting while coordinating cross-functionally.

The role emphasizes training, document control, and adherence to SOPs, with a focus on timely completion of investigations and strong collaboration with QA leadership.