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 Title: Web Developer (ColdFusion Focus) Location: Hybrid Remote Gaithersburg, MD Company: Leading Web Solutions Provider... ...offered. About Us We are a long-established web development firm with over three decades of experience serving associations...
...Receive, register and distributing packages and letters within the company Maintain the company stockroom through organizing, cleaning, and cataloging items Schedule large shipments and plan logistics to ensure that there is sufficient storage space for incoming...
...Description The Holmes Organisation is a full-service risk management agency headquartered in Jacksonville, Florida. We work with businesses and individuals to design... ...educational opportunities Flexibility to work from home Paid maternity leave Enticing PTO plan...
...is more convenient for dog owners and more enjoyable for their pets. We dispatch our purpose built dog grooming vans to our customers... ...care to dogs. This is a great opportunity for someone whos an animal lover and ready for the ins and outs of mobile grooming. The ideal...
High Meadows School in Roswell, Georgia, approximately 30 minutes north of Atlanta, for a full-time, 12-month (occasional weekends and holidays as needed), Monday through Friday, 9:00 a.m. to 6:00 p.m. (with an hour unpaid lunch), School Custodian. This is a non-exempt...