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.
...maintaining a safe and trustworthy hiring experience for all candidates. Loloi is seeking talented and artistic candidates for our Summer 2026 Internship Program . As an intern for product design, you will be immersed in the various functions that contribute to the...
...Enterprise Architect in AI Position Overview We are seeking an Enterprise Architect with... ...patterns: LLM integration, RAG systems AWS Bedrock, SageMaker, OpenAI APIs Cursor... ...Requirements ~10+ years enterprise/solution architecture ~ Software engineering background...
...Job Title: Corporate Equipment Coordinator Reports To : Corporate Equipment Manager FLSA Status: Non- Exempt SUMMARY OF POSITION: This is a non-union position responsible for administrative fleet and equipment activities within a specific area of INTREN...
Lead Apparel Product Designer Location: Hybrid: Minneapolis-Saint Paul, MN Reports to: CEO Type: Full-Time Travel: Occasional About Three Nails Sportswear with Purpose. Three Nails is the fastest growing, faith-driven activewear brand on a mission to inspire...
...Who We Are: Alora Pharmaceuticals is a leading specialty pharmaceutical... ...and are developing a sales team focused on our specialty... ...Specialty Pharmaceutical Sales Representative will promote our ADHD... ...Preferred specialty sales experience calling on pediatrics and psychiatrist...