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.
Job Description At Boeing, we innovate and collaborate to make the world a better place. Were committed to fostering an environment for every teammate thats welcoming, respectful and inclusive, with great opportunity for professional growth. Find your future with us...
...the world is excited to present an opportunity for a Senior UX Designer to help shape the future of their digital ecosystem. As a... ...powers scalable, cohesive, and delightful experiences across the product ecosystem. Your mission: to create a design system that...
...Company Description: Patients Choice Medical is an independently owned rehab company in... ...Technology with wheelchairs in the Medical Sales space. The company's objective is to... ...Description: This is a full-time in-office entry level sales role as a Medical Sales Associate...
...guests, associates, and communitiestreating people like family and creating spaces where everyone feels valued. Now Hiring: Sous Chef Double Cut Steakhouse In this role, youll be responsible for the culinary operations of our popular signature dining...
...Job Title:- Maintenance Supervisor Duration:- 12- Months- position (May go Longer) Location:- Grand Rapids, MI Daily Schedule/Shift Monday-Friday. Will work Saturdays some weeks. Candidate needs to be able to work any shift 1st, 2nd or 3rd Shift. It is common...