CAPA Investigator

Job Description

Duties and Responsibilities:

• Perform non-conformance (Client) investigations within the Trackwise 8 Management System.
• Execute implementation of CAPAs associated with Client 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 client corporate quality requirements.
• Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.

Education and 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.

Knowledge, Skills and Abilities:

• 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.