Microbiology Quality Investigator

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.

• 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.

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

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 Track Wise 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.

• 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.

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