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Quality Laboratory Associate III – Microbial Out of Limits Investigation Owner

Req #: 180001WM_en
Location: Marion, NC US
Job Category: Quality
Date Posted: 1/29/2018 3:19:27 PM
Baxter International

Description

Quality Laboratory Associate III – Microbial Out of Limits Investigation Owner
 
Scope:  The MO Investigator leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence. The Investigator partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs. Interacts with all levels of staff and provides timely updates on investigation status. Manages several investigations at a time.
  • Determines scope, product impact, root cause, corrective and/or preventive actions
  • Assembles cross-functional teams, conducts interviews, observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
  • Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
  • Closes investigations in a timely manner to meet business and compliance needs
  • Works with minimal supervision to drive investigations to closure
  • Works with Subject Matter Experts and Quality Approvers to determine scope, identify root cause(s), and implement corrective/preventive actions
  • Manages investigation and CAPA documentation in TrackWise in compliance with Baxter practices and procedures
  • Understands and implements procedures that support implementation of CAPAs
  • Presents and defends investigations during regulatory inspections, as required

Qualifications

 

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)
  • 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
  • Must have working knowledge of TrackWise system
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 Quality Operations, Microbiology Laboratory, and/or Quality

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.

EEO is the Law
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Pay Transparency Policy

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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