What are the responsibilities and job description for the CAPA/NCR writers position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Perform non-conformance (Client) investigations within the Track Wise 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 Baxter corporate quality requirements.
- Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.
- BS/BA (4 years of university level education) in science, engineering or related field.
- 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.
- 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.
