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.
...seeking a detail-oriented and customer-focused Entry-Level Hotel Coordinator to assist with booking accommodations and managing hotel... ...communication skills, and are passionate about hospitality and travel. You will support clients in selecting the right lodging based...
~ Salary: $75,000-$90,000~ Bonus up to 15-25% of annual salary ~100% Onsite ~100% Paid Healthcare ~ Unlimited PTO Top Skills: ~ Strong C# .NET and SQL Database ~ Modern JavaScript/HTML/CSS web application development using libraries like Blazor
...Do you have experience as a delivery driver? Do you thrive in a fast-paced environment?... ...associated with meal service. Pack meals in transport equipment such as heated caddies, holding... ...vehicles including mileage record, fuel, sanitation, general maintenance, and...
WHO WE ARE Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage...
About Cinq Sept cinq sept sankahset skeset n : The time between late afternoon and early evening when streets are awash in the warm glow of the vanishing sun and anything is possible Sharing its name with the French term for the liminal moment linking late...