Description:
CAPA/NCR writers
12 months contract; May extend
Onsite
Essential Duties and Responsibilities:
1. Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
2. Execute implementation of CAPAs associated with NCR investigations.
3. 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.
4. Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.
Qualifications:
1. Candidate must not be allergic to Penicillins or Cephalosporins
2. Understanding of the product’s intended use and manufacturing process
3. Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.
4. Strong problem solving and analytical skills.
5. Consultation and facilitation skills.
6. Understanding of statistics in support of fact based decision making.
7. Excellent written/verbal communication and organizational skills
8. Ability to make independent decisions with minimum oversight
9. Customer sensitivity / acumen and ability to interact with all levels of management.
10. Experienced user of TrackWise preferred.
11. Working knowledge of FDA Regulations and International Regulatory requirements.
12. Understanding of risk management tools.
13. 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.
Senior Care Assistant Days - Ridgeway Care CentreFull Time Hours Available.St Philip's Care is dedicated to providing outstanding care to our clients which is why weare an award winning company and have been named'The most outstanding care group in the UK'and ...
...Demonstrate hands on experience using the Workday database required ~ Third-party payroll vendor management preferred (ie: One Source Virtual, ADP, etc)~ In-depth knowledge of fundamental payroll principles, including calculations, deductions and tax regulations ~...
Position Summary: Responsible for providing system training and support in the areas of Registration, Scheduling, Charge Entry and Clinical Repository for all new support staff. Promote and enhance on going training for existing employees, as needed. Provide on sight...
About Us Tinci Materials is a global leader in green chemical innovation, specializing in cutting-edge new energy lithium battery materials and high-performance daily cosmetics ingredients. As the world's largest supplier of lithium battery electrolytes, we pride ourselves...
...CNA II | Med/Surg ABOUT CAMPBELL COUNTY HEALTH Campbell County Health (CCH) is more than just a hospitalwe are a comprehensive... ...excellence utilizing AIDET. Enhances patient safety by attending shift huddle, and performance of hourly rounding. Assists with admission...