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.
50% Project Management | 50% Technical Print Execution Were seeking a hybrid Production Designer with strong project management skills to lead the execution of high-quality print materialsflyers, brochures, catalogs, and other educational content. If youre a detail-...
...Mechanical Maintenance Technician/Supervisor (Days)$80,000 - $100,000 + Progression to Manager + Training + 401k + Medical + Dental + Vision Clewiston, Florida (Commutable from: Fort Myers, West Palm Beach, Lehigh Acres, Wellington) Are you Mechanical Maintenance...
Description: Reporting to the Maintenance Manager or the Team Lead in their absence, the maintenance technician is responsible for the general maintenance and repair of apartment units. Main duties include apartment turnovers, work order and preventive maintenance duties...
Company Description At Higher Logic, engagement happens here. As the industry-leading, human-focused engagement platform we deliver powerful online communities and communication tools to organizations looking to build, retain, and grow their member or customer ...
...skills? Join American Freedom Insurance Company (AFIC), a leader in the... ...an impactright from your home office! Why Join AFIC? At... ...Shield PPO, HMO, or HSA plans, dental and vision coverage, Access to... ...Superior rating by A.M. Best Work-Life Balance: Full Remote - Monday...