Description Job Purpose:

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

Essential Duties and Responsibilities:

Effectively completes microbiology excursion reports and associated documentation per procedure within specified timelines. Executes timely completion of CAPAs, Quality Events (QE), memorandums, and deviations as they pertain to the Microbiology program. Coordinates 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). Understands Microbiology-related guidance, including but not limited to USP, FDA, and compendial standards. Prepares reports and data for EM tracking and trending, as well as tracking and reporting excursions, QEs, and CAPAs. Updates and maintains the investigations electronic logs for visibility. Coordinates with impacted departments and Quality Investigations department to ensure oversight of CAPA plans, investigation outcomes, and reduce future events. Maintains adherence to established Standard Operating Procedures (SOPs) and work instructions. Completes Microbiology SOP revisions. Communicates 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:

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