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.
Our client is hiring an Event Coordinator. This position reports to the Member Services Director. The position is primarily responsible for planning, managing, and executing professional events for the company and affiliated businesses. This includes Event Center rental...
...Employment Type: Full-Time Hourly Range: $27-$30 At Medi Home Health & Hospice , part of the Medical Services of America family,... ...currently seeking an experienced Licensed Practical Nurse (LPN) to join our dedicated team, providing meaningful end-of-life care...
...Job Description: Packing Operator (Edible Oil Refinery) Job Responsibilities: Operating and maintaining packaging machinery in... ...products. Essential Qualifications: Minimum of 2 years of experience in operating packaging machinery. Ability to read and...
...Many can take a photo, but few can tell a story. Our mission as a company is to hire talented photographers who are passionate about their work, eager to hone their skills and embrace their creative expression. Our photographers produce exceptionally beautiful photographs...
...Ellucian Banner software. This role may require some after-hours or weekend hours during major upgrades or emergency situations.... ...Core Modules and other functions. Provide support and test remote database administration (DBA). Provide supplemental training...