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CAPA Assoc II

Req #: 180001AZ_en
Location: Marion, NC US
Job Category: Quality
Date Posted: 1/10/2018 3:42:15 PM
Baxter International

Description

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Description
The Investigation Owner is responsible for developing and performing the investigation, identifying the root cause(s) of the event, and documenting the results of the investigation. The IO may also assist in identifying the appropriate actions to mitigate or eliminate the root causes, and in determining an Effectiveness Plan for the actions (including effectiveness criteria and timeframe).      

Essential Duties & Responsibilities
  • Develop the Investigation Plan and present the Investigation Plan and results at stage-gate review. (High CA only). 
  • Determine the Define/Measure/Analyze elements of the investigation.  
  • Determine scope of the investigation. Assume ownership and lead the Investigation phase of a CAPA.
  • Identify appropriate/cross-functional team members and assemble the Investigation Team.  
  • Confirm corrections/containment identified based on the investigation results. 
  • Identify and employ appropriate investigation tools.  
  • Determine the appropriate data sources to be evaluated for the investigation, and obtain the required data 
  • Investigate the root cause(s) of the issue. 
  • Clearly document the investigation results.  
  • Communicate the investigation results to  
  • Ensure investigation follows the CAPA procedure, including all data entry requirements per the checklists. 
  • Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle. 
  • Collaborate with Action Owner/CAPA Owner to develop the Action Plan/Effectiveness Plan.  
  • Document Action Plan.  
  • Document Effectiveness Plan, including acceptance criteria and timeframe/number of opportunities. 

Qualifications

Qualifications for this role

  • Understand strategies and be able to invent new methods or new avenues of investigation. 
  • Thorough knowledge of applicable CAPA procedures, specifications, regulations and standards. 
  • Strong analytical and problem solving skills. 
  • Good communication and leadership skills. 
  • Good interpersonal/communication/influencing/negotiation skills. 
  • Good project management skills. 
  • Working knowledge of FDA regulations and application of Good Manufacturing Practices.  

Education & Experience

Bachelor's degree (in science or engineering preferred) or equivalent experience. 

2+ years of experience in Quality, Manufacturing, Engineering or related field


A Career that Matters

Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.


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

EEO is the law - Poster Supplement

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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.

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