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Quality Associate II, CAPA

Req # JR - 027263 Location Round Lake, Illinois, United States Job Category Quality Control Date posted 09/10/2020

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Summary:

Performs, manages, and coaches nonconformance CAPA investigations, continuous improvement projects, and other quality system projects in direct support of the Drug Delivery aseptic manufacturing facility.  Assists in preparing the plant for regulatory compliance audits.  Leads cross-functional problem solving and process improvement teams.  Must have the ability to manage people, encourage teamwork and drive decisions.

Essential Job Duties and Responsibilities:

  • Perform, review, and approve non-conformance (NCR) and complaint investigations within the Track Wise 8 Management System.
  • Own site’s most complex investigations and CAPAs
  • Prepare monthly, quarterly and annual CAPA metrics/trending for plant and corporate quality reviews.
  • Perform site training on Trackwise NCR/CAPA system and provide ongoing support to manufacturing and quality teams
  • Manage project schedules in achieving defined quality goals in an efficient, accurate and timely manner.
  • Directly involved in and, where appropriate, leads multiple process/product improvement projects which may include any of the following – CAPA Investigations, Complaint Investigations, Kaizan Teams, Change Control Projects, equipment/process validations, development of new procedures and improving existing procedures, data collection and analysis, report development and presentation.
  • Maintains a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements.  Maintains audit ready status for assigned areas and assists other areas within the facility in maintaining compliance with local procedures as well as US & International Regulatory and Baxter corporate quality requirements.
  • Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.

Qualifications:

  • Candidate must not be allergic to Penicillins or Cephalosporins
  • Understanding of the product’s intended use and manufacturing process
  • Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.
  • Strong problem solving and analytical skills.
  • Consultation and facilitation skills.
  • Understanding of statistics in support of fact based decision making.
  • Excellent written/verbal communication and organizational skills
  • Ability to make independent decisions with minimum oversight
  • Customer sensitivity / acumen and ability to interact with all levels of management.
  • Experienced user of TrackWise preferred
  • Working knowledge of FDA Regulations and International Regulatory requirements.
  • Understanding of risk management tools.
  • Available to work during off-shift or weekends as appropriate to support investigations and training

Education and/or Experience:

  • BS/BA (4 years of university level education) in science, engineering or related field. 
  • 2-5 years relevant work experience in cGMP related industry or in a clinical setting.
  • Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools is a plus.

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. 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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