Microbiology Quality Investigator

Description

Job Purpose: (Summarize the job in a few sentences)

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:(list clear and concise job duties specific to the role)

• 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.

Job Specifications and Qualifications: 

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 1bs.), standing,      sitting and walking throughout the facility.
• Hours      of work: Monday through Friday on an 8-hour shift, or as needed based on      company demand. 
• Salary      range: based on education and experience.