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.
...Role Summary: The Dispatcher will act as a communication point for all calls: coordinate requests, transmit messages and track vehicles. This individual would enable different parties to communicate well by ensuring the accurate and timely transmission of information...
...Management Mediation and testimony experience a plus We are an equal opportunity employer, and we are an organization that values diversity. We welcome applications from all qualified candidates, including minorities and persons with disabilities. req25-00682...
...the DMV area. We haveexpanded to eight retail locations, two production bakeries, and a thriving wholesale business. We serve coffee shops, restaurants, hotels, and grocery stores with fresh products every day, 365 days a year. Our mission is to offer our customers...
...H&K Group, Inc. s Chalfont Quarry is searching for a Haul Truck Driver to join their team! The driver operates straight or articulated rubber-tired rock trucks equipped with a hydraulically powered bed to transport and dump material. The ideal candidate is safety...
...Position Summary: The Business Systems Analyst (BSA) is responsible for managing the WMS, ERP, OMS, including the oversight and resolution of EDI issues. The BSA will lead the coordination and resolution of break/fix issues, maintain project lists, gather detailed business...