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.
...Great Life work Balance position with excellent benefits! The CNA or HHA serves as a member of the PACE Interdisciplinary Team. Under the direction of a licensed nurse, incumbent participates in all aspects of the planning, implementation and evaluation of personal care...
...Required Skills: ~2+ years experience working in a data center/critical facility. ~ Experience with building systems, including: UPS systems, emergency generators, and switchgears. ~ Demonstrated verbal/written communication skills. ~ Working knowledge of computer...
...Commercial Lines Underwriter - Remote (Arkansas, Missouri, or Kansas City Metro) A respected insurance organization is seeking an experienced Commercial Lines Underwriter to oversee a high-volume territory with significant underwriting authority. This position offers...
...customers, enhancing their choices and experiences. The Delivery Driver will efficiently deliver products to our customers via a 26FT... ...work environment through the EOS Management System. Our team members actively participate in regularly scheduled L10 Meetings...
Hair & Make-up Designer/Director: Trollwood Performing Arts School Collaborate with professionals from across the nation at Trollwood Performing Arts School, a unique youth arts organization producing a high-quality musical in the outdoor amphitheater at Bluestem Center...