This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/10055106
DESCRIPTION
+ **Only U.S. Citizens and those authorized to work in the U.S. may be considered as W2 candidates.**
+ **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Job Title: Quality Associate IIIRequirement Number: 21777Start date: ASAPDuration or End date: 6 MonthsLocation: Round Lake, IL 60073CAPA/NCR WritersDescription:Essential Duties and Responsibilities:1. Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.2. Execute implementation of CAPAs associated with NCR investigations.3. Maintains a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements. Maintains audit ready status for assigned areas and assists other areas within the facility in maintaining compliance with local procedures as well as US & International Regulatory and Baxter corporate quality requirements.4. Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.Qualifications:1. Candidate must not be allergic to Penicillins or Cephalosporins2. Understanding of the product’s intended use and manufacturing process3. Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.4. Strong problem solving and analytical skills.5. Consultation and facilitation skills.6. Understanding of statistics in support of fact based decision making.7. Excellent written/verbal communication and organizational skills8. Ability to make independent decisions with minimum oversight9. Customer sensitivity / acumen and ability to interact with all levels of management.10. Experienced user of TrackWise preferred.11. Working knowledge of FDA Regulations and International Regulatory requirements.12. Understanding of risk management tools.13. Available to work during off-shift or weekends as appropriate to support investigations and trainingEducation and/or Experience:• BS/BA (4 years of university level education) in science, engineering or related field.• 0-2 years relevant work experience in cGMP related industry or in a clinical setting.• Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools is a plus.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department (https://www.roseint.com/SecureCommunicationSystem/HRPayrollUpload.aspx) .
Rose International has an official agreement (ID #132522), effective Ju ne 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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