Microbiology Quality 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

Overview

Job Purpose: Microbiology Quality Investigators ensure compliance with FDA regulations in the areas of microbiology-related investigations. They are responsible for ensuring the Microbiology department’s adherence to FDA regulations, including completion of non-conformance investigations, drafting memorandums, managing deviations, and implementing robust corrective and preventive actions (CAPAs). A key aspect of the role is effective inter-departmental collaboration to facilitate timely completion of projects. Investigators must manage their workload and adapt to shifting priorities to meet departmental and company demands.

Essential Duties and Responsibilities

• Effectively complete microbiology excursion reports and associated documentation per procedure within specified timelines.
• Execute timely completion of CAPAs, Quality Events (QE), memorandums, and deviations as they pertain to the Microbiology program.
• Coordinate with all areas of Microbiology and other departments to ensure training related to Microbiology excursions and investigations are completed based on findings and associated root cause(s).
• Understand Microbiology-related guidance, including but not limited to USP, FDA, and compendial standards.
• Prepare reports and data for EM tracking and trending, as well as tracking and reporting excursions, QEs, and CAPAs.
• Update and maintain the investigations electronic logs for visibility.
• Coordinate with impacted departments and Quality Investigations department to ensure oversight of CAPA plans, investigation outcomes, and reduction of future events.
• Maintain adherence to established Standard Operating Procedures (SOPs) and work instructions.
• Complete Microbiology SOP revisions.
• Communicate all Microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the Microbiology Investigations Manager, Assistant Director and Director of Microbiology, and VP of Microbiology.

Supplemental Functions

• Copying, filing, and scanning of investigation-related documents.
• Knowledgeable in Adobe Acrobat (PDF) advanced features and workflows.
• Performs other similar duties as required.

Requirements

Knowledge & Skills:

• Technical background preferred, with knowledge of cGMP, and FDA regulations.
• 1–3 years of experience with Microsoft Word, Excel, and PowerPoint preferred.
• Strong writing and organizational skills: experience with technical writing, Root Cause Analysis, and managing multiple projects/assignments simultaneously.
• Strong understanding of document control procedures, standards, and best practices.
• Familiar with document management software, including SharePoint and TrackWise software.
• Effective time management skills including prioritizing and scheduling, as well as the ability to meet all deadlines and manage time effectively.
• Effective communication and interpersonal abilities to work with cross-functional, fast-paced teams.
• Familiar with relevant industry regulations and compliance standards.
• Discretion in handling sensitive and confidential information.
• Strong critical thinking, analytical, problem-solving, and interpersonal skills.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to manage a multitude of resources and to be accurate and current with data and information.

Education/Experience

• Bachelor’s degree preferred with 1-2 years of pharmaceutical experience in Quality systems or Microbiology.
• 1-3 years of experience with MS Word, Excel, and PowerPoint.
• Pharmaceutical technical writing experience, preferred.

Working Conditions / Physical Requirements

• This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.