CAPA Investigator Owner

Actalent is hiring a CAPA Investigations Tech for a global healthcare company in Round Lake, IL area!

Essential Duties and Responsibilities:

• Perform non-conformance NCR investigations within the Track Wise 8 Management System.

• Execute implementation of CAPAs associated with NCR investigations.

• Maintains a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements. Maintains audit ready status for assigned areas and assists other areas within the facility in maintaining compliance with local procedures as well as US International Regulatory and company's corporate quality requirements.

• 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.

Job Type & Location

This is a Contract position based out of Round Lake, IL.

Pay and Benefits

The pay range for this position is $50.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Round Lake,IL.

Application Deadline

This position is anticipated to close on Jan 20, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.