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.
...and clinical skills Excellent interpersonal and communication skills Ability to work collaboratively with a healthcare team Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree, and a valid medical license Have current Wisconsin DEA license...
...providing reasonable accommodation to individuals with disabilities. If you are a qualified individual with a disability and either need assistance applying online or need to request an accommodation during the interview process, email Human Resources at ****@*****.***...
Technical Business Analyst / Technical Writer (Media / Entertainment background must needed) Onsite in Culver City, CA / Sunnyvale, CA from Day 1 (Client prefer local folks)(Travel required 1 or 2 day trip every month to Sunnyvale or Culver City) Hybrid Schedule: 3...
...first work culture built on integrity and excellence We are an equal opportunity employer, and we are an organization that values diversity. We welcome applications from all qualified candidates, including minorities and persons with disabilities. req25-00936...
...Snappr is currently looking for a skilled Food Photographer based in Gainesville, FL to join our team. The ideal candidate will have a strong eye for detail and the creative ability to capture high-quality images of food that highlight texture, color, and presentation...