Microbiology Investigations Lead — CAPA & Compliance

RXinsider LTD.; Columbia (SC); Hybrid; USD 85,000 - 110,000; Full time

Job summary

RXinsider LTD. seeks a Microbiology Investigation Assistant Manager to oversee CAPAs, QEs, deviations and related investigations within Microbiology, ensuring regulatory compliance with FDA guidelines.

This role interfaces with R&D and QC, manages timelines, and maintains complete investigation documentation. The ideal candidate will have 2–3 years in pharmaceutical quality systems and 1–2 years coordinating investigations, with strong communication and leadership skills to drive

Qualifications

• Bachelor’s degree preferred with 2-3 years of pharmaceutical experience in quality systems preferred.
• 1-3 years of experience with MS Word, Excel, PowerPoint.
• 1-2 years management and investigation coordination experience.

Responsibilities

• Manages and provides support for CAPAs, QEs, excursions, memorandums, and deviations in Microbiology.
• Bridges gap between Microbiology and other departments.
• Coordinates investigations with R&D and QC management for clear communication.
• Reviews reports and training to ensure completion of investigation-related training.
• Establishes timelines for investigation phases and overall completion.
• Ensures investigation documentation is complete and current.
• Reviews SOPs for Microbiology and assists in updates.
• Ensures investigations are thorough and timely to meet company needs.
• Collaborates with Quality Investigations Team to address recurring root causes.
• Communicates observations and issues to senior Microbiology leaders.

Skills

Investigation coordination

Quality systems

Written and verbal communication

Project management

Team leadership

Regulatory compliance

Data analysis

Education

Bachelor’s degree in a related field

Tools

MS Word

Excel

PowerPoint

Job description

RXinsider LTD. seeks a Microbiology Investigation Assistant Manager to oversee CAPAs, QEs, deviations and related investigations within Microbiology, ensuring regulatory compliance with FDA guidelines.

This role interfaces with R&D and QC, manages timelines, and maintains complete investigation documentation. The ideal candidate will have 2–3 years in pharmaceutical quality systems and 1–2 years coordinating investigations, with strong communication and leadership skills to drive