CAPA Investigator Owner at Planet Group Belvidere, IL

Planet Group; Belvidere (IL); Vor Ort; USD 55.104 - 73.467; Vollzeit

Zusammenfassung

Planet Group is seeking a CAPA Investigator Owner located in Belvidere, IL. This role involves conducting non-conformance investigations, implementing corrective actions, and ensuring compliance with regulatory requirements. The ideal candidate will have a BS/BA in science or engineering, 2-4 years of relevant work experience, and strong problem-solving skills. Experience with TrackWise and FDA regulations is preferred. The position requires availability for off-shift or weekend work to support investigations.

Qualifikationen

• Experience in cGMP related industry or in a clinical setting (2-4 years).
• Strong understanding of FDA Regulations and International Regulatory requirements.
• Greenbelt certification or equivalent experience is a plus.

Aufgaben

• Perform NCR investigations within the Track Wise Management System.
• Implement CAPAs associated with NCR investigations.
• Maintain compliance with regulatory requirements and procedures.
• Guide and coach less experienced individuals on problem-solving projects.

Kenntnisse

Problem solving skills

Analytical skills

Communication skills

Organizational skills

Customer sensitivity

Ausbildung

BS/BA in science, engineering, or related field

Tools

TrackWise

Jobbeschreibung

CAPA Investigator Owner job at Planet Group. Belvidere, IL.

Target Pay Rate: 40-53.33/hr **salary will be commensurate with experience**

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. Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements. Maintain audit‑ready status for assigned areas and assist 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

• Candidate must not be allergic to Penicillins or Cephalosporins.
• Understanding of the products 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.