Stefanini Group
We are seeking a CAPA Writer in Round Lake, IL.
Contact: Vipul Bhardwaj – 248‑263‑8630 / vipul.bhardwaj@stefanini.com
Work Hours: M‑F (40 hours)
Work Location: Round Lake, IL
Shift: 1st Shift
Responsibilities
Perform non‑conformance (NCR) investigations within the Track Wise 8 Management System.
Execute implementation of CAPAs associated with NCR investigations.
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.
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 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/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.
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Contact: Vipul Bhardwaj – 248‑263‑8630 / vipul.bhardwaj@stefanini.com
Work Hours: M‑F (40 hours)
Work Location: Round Lake, IL
Shift: 1st Shift
Responsibilities
Perform non‑conformance (NCR) investigations within the Track Wise 8 Management System.
Execute implementation of CAPAs associated with NCR investigations.
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.
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 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/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.
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