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.
...specifically ARGUS Enterprise. The ideal candidate will have strong financial and analytical skills, preferably with prior analyst, broker, or investment experience, and a solid understanding of commercial real estate operations. This is a 5-day, in-office role based...
...Work with logistics manager to support on time shipments. Willingness to accept new and challenging projects Education, Experience, and Technical Knowledge ~ BS degree in Business or related field. ~2-4 years of purchasing experience in a manufacturing or...
...REQUIRED (CAN BE OBTAINED AFTER EMPLOYMENT)_______________________________________________________________________ Job Type: Part-time Pay: $17.00 per hour Expected hours: 16 per week Benefits: Employee discount Paid orientation Paid training...
Class A Class A Tanker Driver JobPLEASE READ ENTIRE AD!!! Experienced Class A driver, must have Tanker and Hazardous endorsement. You will need a good driving record, we prefer 2 years verifiable experience driving a tractor trailer combination but for the right individual...
Title: Certified Medical Assistant - Specialty is Family Medicine Day-to-Day: Rooming In basket Management Paperwork management Immunizations Referrals Schedule: M-F 4x10s, day off Wednesday or Thursday to be determined after start, first two weeks...