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USA - CAPA Investigator Owner

Round Lake, IL 60073

Posted: 11/12/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 623362 Is job remote?: No Country: United States

Job Description

Pay range: 57-67/hr 
*depending on experience
 
Description:
CAPA/NCR writers

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 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 Cephalosporins
2. Understanding of the products intended use and manufacturing process
3. 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 skills
8. Ability to make independent decisions with minimum oversight
9. 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 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.
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About Round Lake, IL

Ready to kickstart your career in the vibrant Round Lake, Illinois area? Our job listings are brimming with enticing opportunities waiting to be explored! Nestled in Lake County, Illinois, Round Lake boasts a perfect blend of small-town charm and big-city amenities. With proximity to iconic landmarks like the Chain O'Lakes State Park and the renowned Genesee Theatre, there's no shortage of recreational activities and cultural experiences here. Indulge in the local cuisine at Round Lake's charming eateries, catch a show at the state-of-the-art Round Lake Area Park District's Cultural & Civic Center, or cheer for the Chicago Bears at the nearby Soldier Field. Discover why Round Lake, IL is not just a place to work, but a place to thrive and find fulfillment in your career journey.