Quality Analyst II
BaxterBrooklyn parkUpdate time: November 12,2019
Job Description

Are you looking for a career that matters?

We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

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Summary

  • Compile data and conduct Management Review and drive actions coming from the meeting
  • Responsible for reviewing pertinent documents, records and reports against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
  • Identify areas of non-conformance and inform management as needed to be disposed (unilaterally accepted or rejected) by others. NCRs at this level are minor.
  • Performs initial investigative actions on some NCRs, applying well-established techniques and procedures.
  • Revise or review standard procedures.
  • Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
  • Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.

Requirements

  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a strong team player with good problems solving, and good verbal and written communication skills.
  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

Education

  • BS in business/science or equivalent degree.
  • 4-6 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.

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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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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