SPECTRAFORCE · 11 hours ago
NCR & CAPA Specialist
Round Lake, IL
Contract
Onsite
Entry, Mid Level
2+ years expSPECTRAFORCE is seeking an NCR & CAPA Specialist to perform non-conformance investigations and implement corrective and preventive actions. The role requires maintaining compliance with regulatory requirements and providing guidance on process improvement projects.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Naina Rathi
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 Baxter 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
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
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
Preferred
Experienced user of TrackWise preferred
Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools is a plus
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase