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CAPA Investigator Owner
120 West Belvidere Road Hainesville, IL 60073 US
Job Description
Target Pay Rate: 40-53.33/hr **salary will be commensurate with experience
Description:
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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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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