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.
...want Earn cash working part time or full time. Learn new skills that you can take anywhere. No degree required Supplement your existing job. No need to quit your current job, unless you really hate it....
...Integrating self within external organization Experience managing high volume of projects simultaneously Proactive Searching... ...knowledge of the product Knowledge of quality standards Aviation industry experience required Knowledge of general certification...
SHOP MANAGER WHO YOU ARE: Our leaders at Michael Kors are stylish, driven, multi-tasking individuals who are customer service focused brand ambassadors. Success starts with being an entrepreneur we encourage an innovative workplace to creatively deliver results...
...A client of I.K. Hofmanns is looking to bring on a Construction Materials Testing/Inspection Technician. This person will be responsible for testing the quality of concrete and more construction materials to guarantee strength and reliability. If you are ok with driving...
Title:- Medical Information Specialist II (Clinical) Location: Morristown , NJ 100% Remote Duration: Contract until Oct 2026 (Possible extension) Description: Medical Information Specialist will: Manage and maintain scientifically accurate local and global...