CAPA Compliance Manager
Spectraforce
Newark, Delaware
4 hours ago
Job Description
Position Title: CAPA Compliance Manager
Work Location: Either Newark, DE 19702 or Marlborough, MA 01752
Assignment Duration: 6 Months
Work Arrangement: Open to 100% remote for the right candidate, ideally onsite at either Newark or Marlborough, MA
Key Responsibilities:
- CAPA Review Board - prepare material, generate data for charts (21 data sets / charts), analyze trends, provide talking points, load minutes and attendance to Agile
- KPI Meeting - prepare material, generate data for charts (duplicates CRB except 2 NCE charts), analyze trends, and provide talking points
- Process change orders for Corporate CAPA and NCE documents o Corporate CAPA and NCE procedures and work instructions o Agile-CAPA and Agile-NCE validation and specification documents o Administrative files for Agile-CAPA and Agile-NCE, e.g. Dropdown lists
- Facilitating CAPAs and NCEs
- Preparing and distributing quarterly Overdue CAPA/IACA report
- Preparing and distributing monthly CAPA Aging report to QLT
- Review and approving Agile access requests - CAPA, NCE
- Periodic review of open COR, CAPA, and NCEs (globally)
- Validate and test Agile-CAPA and Agile-NCE tool changes
- Author validation/specification documents for Agile-CAPA and Agile-NCE, e.g. SRS, SDD
- Maintain CAPA/NCE SharePoint page
- Collaborate with AI team to establish AI proof of concept for identifying potential compliance issues in CAPAs
- Ad hoc data analysis
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 110.00/hr.