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Quality Associate II - Operations (1st shift)

Company: BAXTER
Location: Unionville
Posted on: August 7, 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. SummaryThe Quality Associate II Line Operations is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Supervisor. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during the manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter Standard Operating Procedures. They facilitate training of new Quality Associates in QALO. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)

  • Facilitates training qualifications and on-going support for associates, including activities such as aseptic intervention oversight, room inspections, line clearances, oversight checklists, logbook review, work order review, and equipment chart review
  • Leads cross functional continuous improvement project teams utilizing Lean principles
  • Serves as principal Quality author for Significant (potential batch impact) Nonconformance Reports
  • Provides technical support and guidance to nonconformance authors
  • Acts as team leader to shift associates in absence of supervisor
  • Assists supervisor in maintenance of visual controls and accountability tools
  • Ensures compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety.
  • Reviews records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
  • Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
  • Performs Quality functions in classified areas, including checklists, aseptic intervention oversight, and line clearances.
  • Reviews completed terminal sterilizer, lyophilizer, depyrogenation and autoclave charts as well as filter integrity testing results.
  • Provides review of proposed standard operating procedure revisions.
  • Works in collaboration with management team to prepare for internal and external audits. Assists with timely closure of audit observations.
  • Authors Nonconformance Reports, Risk Assessments, and corrective action responses for exception variances.
  • Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
  • Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation. Job Requirements (Education, Experience and Qualifications)
    • Bachelor s degree in a science discipline (preferably Chemistry or Microbiology) with 2 years experience in Pharmaceutical Quality or Manufacturing, or Bachelor s degree in non-science discipline with 5 years of Pharmaceutical Quality or Manufacturing experience
    • Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required.
    • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)Physical / Safety Requirements
      • Must wear appropriate PPE as required for various manufacturing areas
      • Must be able to gown qualify for Grade A/B areas.
      • Duties may require overtime work, including nights and weekends
      • Use of hands and fingers to manipulate office equipment is required
      • Position requires sitting for long hours, but may involve walking or standing for periods of time. The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law. 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. 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 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 link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter 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 Recruitment Fraud Notice . 070961

Keywords: BAXTER, Bloomington , Quality Associate II - Operations (1st shift), Other , Unionville, Indiana

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