Regulatory & CAPA Coordinator

Job Title : Regulatory & CAPA Coordinator

Location : Round Lake, IL (Onsite)

Experience : 2 4 years

Duration : 12+ months contract (may extend or convert to full-time)

Citizenship : USC / Green Card required

Local / In-state candidates preferred

Job Summary :

We are seeking a detail-oriented Regulatory & CAPA Coordinator to perform non-conformance investigations and implement corrective and preventive actions (CAPAs) within a regulated manufacturing environment. The role requires maintaining regulatory compliance, supporting process improvement initiatives, and mentoring less experienced team members.

Key Responsibilities :

Conduct non-conformance (NCR) investigations using TrackWise 8 or similar management systems.

Execute CAPAs related to NCR investigations.

Maintain expertise in current regulatory requirements and ensure assigned areas are audit-ready.

Assist other areas in compliance with local procedures, US and international regulations, and corporate quality standards.

Guide and coach team members on DMAIC problem-solving and process improvement projects.

Qualifications :

Must not be allergic to Penicillins or Cephalosporins.

Understanding of the product's intended use and manufacturing process.

Ability to prioritize multiple tasks to meet compliance and procedural requirements.

Strong problem-solving, analytical, consultation, and facilitation skills.

Knowledge of statistics to support fact-based decision making.

Excellent written, verbal, and organizational skills.

Ability to make independent decisions with minimal oversight.

Customer-focused mindset with ability to interact with all levels of management.

Experienced user of TrackWise preferred.

Working knowledge of FDA and international regulatory requirements.

Understanding of risk management tools.

Flexibility to work off-shift or weekends as needed to support investigations and training.

Education & Experience :

BS / BA in Science, Engineering, or related field.

2 4 years of relevant work experience in a cGMP-regulated industry or clinical setting.

Greenbelt certification or equivalent experience in Six Sigma or Lean Manufacturing is a plus.