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Quality Analyst (medical devices; batch records)

Company: Kelly Services
Location: Bloomington
Posted on: April 9, 2021

Job Description:

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 12+ month, long term contract--opportunity as a Quality Analyst for a top fortune 500 company in Bloomington IN.--Title: Quality Analyst (medical devices; batch records)Duration: 12+ monthsLocation: Bloomington INShift: 1st shift; 6:30a-3pPay Rate: $24-25/hr--Essential Duties and Responsibilities:

  • The GMP Batch Record Reviewer is a member of the Finishing Department reporting directly to the Packaging Supervisor, Production.
  • He or she performs review of all quality documentation generated during filling operations.
  • He or she performs review of all quality documentation generated during packaging operations.
  • He or she must communicate effectively with customer support departments to coordinate batch review and release activities to meet internal commitments and contractual commitments.
  • He or she must communicate effectively with production and customer support departments to coordinate batch review activities to meet internal commitments.
  • Perform batch record review for GMP batches produced at client site for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
  • Reconcile discrepancies with documentation and/or electronic systems as appropriate.
  • Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Production review of batch records in order to achieve internal targets and contractual commitments for batch release.
  • Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
  • Perform final batch record review, product release / disposition of GMP batches produced.--Qualifications: --
    • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
    • Duties may require overtime work, including nights and weekends
    • Use of hands and fingers to manipulate office equipment is required
    • Position may require standing for long periods of time.--Education / Experience:
      • Bachelor's degree in a science discipline or Bachelor's degree in non-science discipline with at least three years of Pharmaceutical Quality or Manufacturing experience.--Important information:--This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira () for immediate consideration.--Why Kelly?
        • As a Kelly Services employee, you will have access to numerous perks, including:
          • Exposure to a variety of career opportunities as a result of our expansive network of client companies
          • A competitive hourly pay rate with weekly checks
          • Access to newly expanded Medical Plan options
          • Online continuing education via the Kelly Learning Center
          • Several employee discounts
          • And more!--Why Kelly--?Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]

Keywords: Kelly Services, Bloomington , Quality Analyst (medical devices; batch records), Professions , Bloomington, Indiana

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