Job Title : CAPA Investigator Owner
Location: 12 months
Duration: Round Lake IL 60073

• 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 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 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

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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 60.00/hr.