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.
...decisive, dynamic, and a thought leader. Ability to work well under stress and with a sense of urgency to meet deadlines. Homecare Homebase software experience a plus. Computer literate Professional Requirements: Excellent communication skills. Bilingual...
Company Description Boyd Gaming Corporation has been successful in gaming jurisdiction in which we operate in the United States and is one of the premier casino entertainment companies in the United States. Never content to rest upon our successes, we will continue ...
...Job Title: Desktop Engineer / Deskside Support Location: Prosper, TX Job Type: Contract-to-Hire Schedule: MondayFriday, 8:00 AM 5:00 PM Position Summary: Our client is seeking experienced Desktop Engineers to provide deskside support in an enterprise...
...Senior Project Accountant |$36.00$40.00| 8 am 5 pm / Day Shift / Onsite/ Long-Term Contract What Matters Most Competitive Pay of $36.00-40.00 per hour Schedule: Mon Fri / 8 am 5 pm Location: Pearland, TX 77581 Long term contract Weekly Pay with...
...aspects of contracts to protect companys interests and simultaneously maintain good relationships with the customer, architects and contractors Procure supplies, materials, labor, and contractors to complete the project Interpret and explain plans and contract terms...