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.
...Overview : As a Product Development Assistant for women's apparel, you will be a crucial part of our product development team, ensuring the successful execution of clothing items from concept to launch. Your role will involve managing deadlines, facilitating communication...
...behalf of a partner company. We are currently looking for a UX/UI Designer in the United States . In this role, youll help create seamless... ...steps (such as interviews or assessments) are made by their internal hiring team. Thank you for your interest!#LI-CL1...
...States without the need for current or future visa sponsorship." Overview: Family Dollar is seeking a results-driven Sr. Industrial Engineer to join our national supply chain network of Distribution Centers. This role will focus on supporting labor management...
...Join Our Team! Event Ticket Fulfillment Associate (Day Shift) About Us Were industry veterans with a fresh perspective on the ticketing industry. Our mission is simple: provide fans across the nation with access to live events and shows while delivering an exceptional...
...high-volume inbound and outbound contact. This remote-friendly, work-from-home role emphasizes consultative selling, pipeline management,... ...Qualifications High school diploma or equivalent; college students, recent graduates, interns, and career changers are encouraged...