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.
...collaborative Business Analyst/Product Owner to join our client's web development team. This role serves as the critical bridge... ...Write clear, detailed user stories and acceptance criteria that developers can execute Collaborate with stakeholders to ensure requirements...
...benefit gather across dental or medical payers, clean pre-... ...insurance processing, and a positive experience for patients and supported offices... ..., claim submission, charging/coding requirements, insurance AR... ...Certified Professional Coder (CPC) or Certified Revenue Cycle...
Job Description: Operate a hydraulic lattice boom or telescoping type crane to hoist and move materials, raise and lower heavy weights and perform other related operations. Licenses and Certifications: Valid, OSHA-recognized crane operator certification (NCCER, NCCCO...
We are currently seeking an experienced AP Specialist / Junior Accountant to fill an opening with a client local to the Atlanta market. This role is ideal for an accounting professional with 12 years of corporate accounting experience who is looking to continue building...
Description: Direct Support SpecialistChaska, MN Job Type Full Time Description Looking to elevate your Direct Care experience? Pinnacle Services is seeking dedicated, caring individuals to join our team as Direct Support Specialists ! Our Direct...