Stefanini Group is hiring: CAPA Writer in Round Lake

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.