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Sr Auditor, Quality

Company: BAXTER
Location: Bloomington
Posted on: January 15, 2022

Job Description:

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You 'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. -Baxter 's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. -Join us at the intersection of saving and sustaining lives - where your purpose accelerates our mission. -SummaryConducts external and internal compliance audits ensuring compliance with all applicable processes, systems and provisions of the Quality System, including regulatory requirements. - -Essential Duties and Responsibilities

  • Maintain Quality Systems in accordance with applicable regulatory requirements.
  • Prepare for Internal and Client audits by researching background information, including previous audit results.
  • Perform -internal audits -by collecting and analyzing objective evidence regarding issues and risks. Report findings to management team.
  • Host routine audits conducted by the company's contract manufacturing clients.
  • Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Communicate issues to management team.
  • Manage the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of audit-related corrective and preventive actions.
  • Manage the assessment file through the process to closure.
  • Perform follow-up audits to confirm corrective and preventive action is effective.
  • Remain current in regulatory knowledge through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, Internet or other literature.
  • Support and participate with management during external regulatory and corporate -inspections as needed.
  • Prepare management reports depicting trends for management review purposes.
  • Conduct and report on gap assessments against regulations, regulatory findings, and Corporate procedures.
  • Perform supplier quality responsibilities as applicable to local site.
  • Perform Compliance/Standards Impact Analyses for Change Control.
  • Perform Quality approval and Periodic Review for Standard Operating Procedure revisions that impact Compliance.
  • Participate in continuous improvement initiatives.Qualifications
    • Extensive working knowledge of applicable quality and regulatory standards and regulations.
    • Excellent communication skills - both written and oral.
    • Work effectively independently and in team environment.
    • Must demonstrate sound judgment and analytical skills to enable assessment of risk.
    • Expertise in GMP regulations (21 CFR Parts 11, 201/211, EudraLex Volume 4, PIC/S PE-0015.
    • Ability to demonstrate strong organizational skills.
    • Good working knowledge of Windows based applications.
    • Resourceful, self-reliant, self-motivated and confident.
    • Working knowledge of quality software system (e.g. TrackWise).
    • General knowledge of Lean Six Sigma and other continuous improvement tools.Education and/or Experience
      • Bachelor degree in a scientific discipline required
      • ASQ and/or RAB auditor accreditation is strongly preferred.
      • Minimum of 5 years of related Quality auditing experience in cGMP environments with particular experience in -pharmaceutical aseptic manufacturing.Equal Employment OpportunityBaxter 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. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our . 054322

Keywords: BAXTER, Bloomington , Sr Auditor, Quality, Accounting, Auditing , Bloomington, Indiana

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