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Description
12 months contract; May extend. Essential Duties and Responsibilities
Perform non-conformance (NCR) investigations within the Track Wise 8 Management System. Execute implementation of CAPAs associated with NCR investigations. 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 corporate quality requirements. Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant. Qualifications
Candidate must not be allergic to Penicillins or Cephalosporins Understanding of the product's intended use and manufacturing process Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures. Strong problem solving and analytical skills. Consultation and facilitation skills. Understanding of statistics in support of fact based decision making. Excellent written/verbal communication and organizational skills Ability to make independent decisions with minimum oversight Customer sensitivity / acumen and ability to interact with all levels of management. Experienced user of TrackWise preferred. Working knowledge of FDA Regulations and International Regulatory requirements. Understanding of risk management tools. Available to work during off-shift or weekends as appropriate to support investigations and training Education and/or Experience
BS/BA (4 years of university level education) in science, engineering or related field. 2-4 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. Seniority level
Entry level Employment type
Contract Job function
Other, Information Technology, and Management Industries
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12 months contract; May extend. Essential Duties and Responsibilities
Perform non-conformance (NCR) investigations within the Track Wise 8 Management System. Execute implementation of CAPAs associated with NCR investigations. 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 corporate quality requirements. Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant. Qualifications
Candidate must not be allergic to Penicillins or Cephalosporins Understanding of the product's intended use and manufacturing process Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures. Strong problem solving and analytical skills. Consultation and facilitation skills. Understanding of statistics in support of fact based decision making. Excellent written/verbal communication and organizational skills Ability to make independent decisions with minimum oversight Customer sensitivity / acumen and ability to interact with all levels of management. Experienced user of TrackWise preferred. Working knowledge of FDA Regulations and International Regulatory requirements. Understanding of risk management tools. Available to work during off-shift or weekends as appropriate to support investigations and training Education and/or Experience
BS/BA (4 years of university level education) in science, engineering or related field. 2-4 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. Seniority level
Entry level Employment type
Contract Job function
Other, Information Technology, and Management Industries
Software Development Referrals increase your chances of interviewing at Jobs via Dice by 2x Sign in to set job alerts for “Investigator” roles. North Chicago, IL $127,822.50-$178,500.00 2 weeks ago Barrington, IL $82,000.00-$93,000.00 1 month ago Analyst, Crisis Management & Business Resilience North Chicago, IL $82,500.00-$157,500.00 2 weeks ago Analytics Consulting Services Corporate Internship - Summer 2026 (Undergrad) Elgin, IL $81,000.00-$101,000.00 1 week ago Schaumburg, IL $84,000.00-$105,000.00 1 day ago Analyst, Crisis Management & Business Resilience Manager- Senior Data/Business Analyst, AbbVie Complete Access North Chicago, IL $94,000.00-$178,500.00 1 week ago Supply Chain Analyst – Secondary Sourcing Board Certified Behavior Analyst (BCBA)- School based- Short term coverage Rolling Meadows, IL $84,500.00-$165,000.00 2 weeks ago Configuration/Data Management Analyst - R10207300 Rolling Meadows, IL $70,600.00-$105,800.00 1 month ago Business Analyst (Hybrid, Schaumburg, IL) Schaumburg, IL $86,000.00-$107,000.00 2 weeks ago Des Plaines, IL $75,000.00-$95,000.00 1 week ago AI Business Analyst - Temp to Hire - Hybrid Rolling Meadows, IL $80,500.00-$157,000.00 2 weeks ago Analyst, Compliance Auditing, Monitoring and Analytics Analyst, Compliance Auditing, Monitoring and Analytics Bannockburn, IL $70,218.51-$117,008.35 2 days ago Des Plaines, IL $50,000.00-$60,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr