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.
Meta Ads Execution & AnalysisAnalysis of in-house mall sales/traffic dataLocalization of our contents/utilizationInfluencer collaboration and branded content planningContents Commerce Platform Operation
...prosocial behaviors and successful interpersonal relationships, provides the accountability necessary to achieving established goals, and mentors participants as they receive supportive services and attend court dates. As such, this role is a critical component of the long-...
...Today in 2024 because a company that helps people move better should also know how to move out of your way when you need a mental health day. Sick of fluorescent lights, endless note templates, and the same exact treatment plan for everyone? At Visiting Rehab and...
...Operational Technical Services (OTS) is one of the fastest growing private water and wastewater... ...supervision of the Lead Operator and Plant Manager. The applicant will learn and perform... ...and flow regulators, analyzers, chemical feed systems, and aeration blowers. MBR...
...offering compassionate and comprehensive care to underserved communities. We are committed... ...- Champion Patient Care Provide Primary Care coverage to patients in need within... ...English (Preferred but not required). As a Physician at TrueCare, you wont just oversee care...