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Quality Laboratory Associate III – Microbiology Investigation

Req # JR - 049087 Location Marion, North Carolina, United States Job Category Microbiology Date posted 09/15/2021

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Quality Laboratory Associate III – Microbiology Investigation

Summary

The role of Quality Laboratory Associate III (QLAIII) – Microbiology Investigator is primarily responsible for conducting investigation of microbial out of limits (MO) that occur in cleanroom locations including environmental and product solution excursions. 

This role is responsible for the following:

  • Conducting the investigation of these occurrences using root cause analysis tools to determine potential root cause and contributing factors and defining effective corrective and/or preventive actions (CAPA) to prevent recurrence
  • Partnering with other departments throughout the facility including Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs.  
  • Ownership of nonconformance investigations related to contamination control topics, including but not limited to investigation of trends in microbial out of limit types and/or significant nonconformances with high complexity, large scope, high potential for product impact and/or microbial related events which are determined to be systemic in nature. 
  • Assembling cross-functional teams, conducts interviews, observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
  • Fostering collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
  • Closing investigations in a timely manner to meet business and compliance needs
  • Working with minimal supervision to drive investigations to closure
  • Working with Subject Matter Experts and Quality Approvers to determine scope, identify root cause(s), and implement corrective/preventive actions
  • Managing investigation and CAPA documentation in TrackWise in compliance with Baxter practices and procedures
  • Presenting investigations during regulatory inspections

Qualifications, Knowledge, and Skills Required

  •  Strong communication and project management skills
  • Must have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices
  • Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC, Fishbone Diagram)
  • Must have strong technical writing skills and able to put complex thoughts and issues into writing in such a manner that can be understood by the reader
  • Must be able to interact with, and influence others at various levels in multiple departments
  • Must have knowledge of FDA quality systems regulations, preferably experience interacting with FDA or similar regulatory agencies

Education

  • Bachelor or Master’s degree in science, preferably in Microbiology, with 2-3 years of experience in conducting root cause investigations in the pharmaceutical/medical products industry
  • Minimum of 5 years of experience in a quality-oriented role such as Quality Operations, Quality Laboratory or Quality Systems

Other Duties as Assigned

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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