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.
...providing reasonable accommodation to individuals with disabilities. If you are a qualified individual with a disability and either need assistance applying online or need to request an accommodation during the interview process, email Human Resources at ****@*****.***...
...CNA II | Med/Surg ABOUT CAMPBELL COUNTY HEALTH Campbell County Health (CCH) is more than just a hospitalwe are a comprehensive... ...excellence utilizing AIDET. Enhances patient safety by attending shift huddle, and performance of hourly rounding. Assists with admission...
...global electronics company to recruit for an Experience & Showroom Coordinator. This position will be 5 days onsite in Stamford, CT. The role... ...customer experience. Our environment is not a typical corporate event space. You will be part of a team with a strong collaborative...
Job Details: Position: Delivery driver Pay: $400 - $1,300 per week (paid per delivery) Job Type:Independent Contractor/Courier Schedule: Monday through Friday (Saturday Availability) Location: Englewood, CO 80110 Job Summary: Ameriship Parcel Delivery...
Ecommerce Specialist / Wizard St. Paul, MN (On-site) About Wrap-It Storage Were Wrap-It Storage a fast-growing , family-owned company on a mission to help people Get Untangled! And, well, just plain organized. Were a lean (but mighty!) team where ideas...