Katalyst CRO
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CAPA Investigator Owner
role at
Katalyst CRO .
Responsibilities
Perform non-conformance (Client) investigations within the Track Wise 8 Management System.
Execute implementation of CAPAs associated with Client investigations.
Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance with 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 and international regulatory and client corporate quality requirements.
Provide guidance and coaching on performance of DMAIC problem‑solving and process improvement projects for less experienced individuals within the plant.
Requirements
BS/BA (4 years of university‑level education) in science, engineering, or related field.
2–4 years relevant work experience in a cGMP‑related industry or in a clinical setting.
Greenbelt certification or equivalent experience using Six Sigma or other Lean manufacturing tools is a plus.
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 and 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 Track Wise (preferred).
Working knowledge of FDA regulations and international regulatory requirements.
Understanding of risk‑management tools.Availability to work during off‑shift or weekends as appropriate to support investigations and training.
Position Details
Seniority level: Entry level
Employment type: Full‑time
Job function: Other, Information Technology, and Management
Industry: Security and Investigations
Location: Round Lake, IL
Salary range: $70,000–$110,000
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CAPA Investigator Owner
role at
Katalyst CRO .
Responsibilities
Perform non-conformance (Client) investigations within the Track Wise 8 Management System.
Execute implementation of CAPAs associated with Client investigations.
Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance with 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 and international regulatory and client corporate quality requirements.
Provide guidance and coaching on performance of DMAIC problem‑solving and process improvement projects for less experienced individuals within the plant.
Requirements
BS/BA (4 years of university‑level education) in science, engineering, or related field.
2–4 years relevant work experience in a cGMP‑related industry or in a clinical setting.
Greenbelt certification or equivalent experience using Six Sigma or other Lean manufacturing tools is a plus.
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 and 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 Track Wise (preferred).
Working knowledge of FDA regulations and international regulatory requirements.
Understanding of risk‑management tools.Availability to work during off‑shift or weekends as appropriate to support investigations and training.
Position Details
Seniority level: Entry level
Employment type: Full‑time
Job function: Other, Information Technology, and Management
Industry: Security and Investigations
Location: Round Lake, IL
Salary range: $70,000–$110,000
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