Rose International ยท 11 hours ago
Corrective and Preventive Actions (CAPA) Nonconformance (NCR)Writer
Round Lake, IL
Full-time
Onsite
Entry, Mid Level
$50/hr - $57/hr
2+ years expRose International is a company in the healthcare industry seeking a CAPA/NCR Writer to perform non-conformance investigations and implement corrective actions. The role requires maintaining regulatory compliance and providing guidance on problem-solving projects within the plant.
Human ResourcesInformation TechnologyOutsourcingProject ManagementStaffing Agency
No H1B
Responsibilities
Perform non-conformance (NCR) investigations within the Track Wise 8 Management System
Execute implementation of CAPAs associated with NCR investigations
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 corporate quality requirements
Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant
Qualification
Required
Bachelor's in Science, Engineering or related field
2-4 years relevant work experience in cGMP related industry or in a clinical setting
Candidate must not be allergic to Penicillins or Cephalosporins
Understanding of the product's intended use and manufacturing process
Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures
Strong problem solving and analytical skills
Consultation and facilitation skills
Understanding of statistics in support of fact based decision making
Excellent written/verbal communication and organizational skills
Ability to make independent decisions with minimum oversight
Customer sensitivity / acumen and ability to interact with all levels of management
Working knowledge of FDA Regulations and International Regulatory requirements
Understanding of risk management tools
Available to work during off-shift or weekends as appropriate to support investigations and training
Preferred
Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools is a plus
Experienced user of TrackWise preferred
Company
Rose International
Rose International is provider of Workforce Solutions and Information Technology Solutions .
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Eric Token
Chief Revenue Officer (CRO)
Sue Bhatia
Founder and Chairwoman
Recent News
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