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 optimization of our enterprise-scale network infrastructure. The ideal candidate will have extensive, hands-on experience with Cisco technologies -particularly ACI, FTD, and Secure Access -to deliver secure, reliable, and high-performance network operations across...
About 2nd Family Dream big. Make an impact. Change lives. At 2nd Family, were not just building a businesswere shaping the future of in-home senior care. Our mission is to provide compassionate, life-changing support for older adults and their families, and were...
...working directly with children from birth to age fiveincluding experience supporting children with special needsis required. Spanish bilingual skills are strongly preferred. Licenses & Certifications Valid California drivers license and access to a personal...
...Job Title: Model Home Specialist Company: Westin Homes Location: Full-Time, On-site, Sugar Land, TX Summary/Overview:... ...and schedules. Proficiency in Technical Drawing Software: Experience using AutoCAD or SketchUp to create diagrams and drawings. Resourcefulness...
Forklift Mechanic Location: Silverdale, Washington Schedule: Full-time | On-site Summary: We are seeking an experienced Forklift Mechanic to join our team in Silverdale, WA. The Forklift Mechanic will diagnose, repair, and maintain a variety of Material Handling...