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.
...As the Senior Manager of Service reporting directly to the Managing Director, you will be a dynamic leader with direct reports, demonstrating... ..., vision and life insurance plans built to support diverse lifestyles, offer preventative care, and protect against hardship. ~...
Experienced Cabinetmaker / Woodworker Our experienced custom cabinetry woodworkers define high qualify craftsmanship. From the attention to detail, precise measurements, and perfect finishes, our entire process is thoroughly managed as we strive to ensure the highest...
..., independent, multi-family office, and private investment firm. Cressets goal is to reinvent... ...Description Cresset is seeking an Associate, Private Wealth Client Services with... ...organizational interests, all employees receive equity in Cresset. Equal Employment...
...: Full-time AdvizorPro is a fast-growing SaaS company powering sales and marketing teams in the financial services space. We work with asset managers, wealthtech platforms, and service providers to help them identify, connect with, and convert their ideal customers...
...encourage all candidates of diverse backgrounds and lived experiences to apply. A Brief Overview Reports to the Maintenance Supervisor Plumbing/Painting. Responsible for preventative and corrective maintenance, building alterations, and new construction of the...