A CAPA Investigator Owner is needed for medical device company that primarily focuses on products to treat kidney disease, and other chronic and acute medical conditions, in the Round Lake, IL area.
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.
location: Round Lake, Illinois
job type: Contract
salary: $57.70 - 62.70 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Perform Non-Conformance Report (NCR) investigations using the TrackWise 8 Management System.
- Execute the implementation of Corrective and Preventive Actions (CAPAs) linked to NCR investigations.
- Maintain a high level of expertise in current regulatory requirements.
- Serve as a plant resource for compliance with regulatory requirements.
- Maintain audit-ready status for assigned areas.
- Assist other facility areas in maintaining compliance with local procedures, US & International Regulatory, and corporate quality requirements.
- Provide guidance and coaching on DMAIC problem solving and process improvement projects for less experienced staff.
- Must not be allergic to Penicillins or Cephalosporins.
- Possess an understanding of the product's intended use and the manufacturing process.
- Ability to prioritize multiple tasks to ensure compliance.
- strong problem solving and analytical skills.
- Possess consultation and facilitation skills.
- Understand statistics to support 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.
- TrackWise experience is preferred.
- Working knowledge of FDA Regulations and International Regulatory requirements.
- Understand risk management tools.
- BS/BA in science, engineering, or related field.
- 2-4 years relevant work experience in cGMP related industry or in a clinical setting.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
