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 Description Aramark Healthcare+ is seeking candidates for a Coffee Shop Manager position to oversee specialty coffee dining and assist with other retail operations at Chestnut Hill Hospital, located in Philadelphia, PA. This is a management position, responsible...
In todays rapidly evolving landscape, agility and efficiency are critical to maintaining national competitiveness. The ability to integrate specialized expertise into government and commercial organizations is essential for driving tangible improvements in performance...
...Company Description Project Fixers is an expert IT program management consulting company located in Seattle, WA. We specialize in managing delivery of highly complex IT programs, including major system implementations, integrations, and digital transformations. We also...
...weekend(s).*** Launch or Grow Your Career in Post-Acute Care! Are you a Physician Assistant (PA-C) looking for a rewarding and high-paying career with work-life balance? Whether you're an experienced provider or a recent graduate eager to learn, we provide the...
...collaborative and passionate team of dynamic therapists Make a real impact in a rewarding... ...: Minimum of a bachelors degree in Occupational Therapy from a college or university... ...in the home, community, workplace, or school, Rehab Without Walls promotes greater health...