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Omni Inclusive
Quality - Quality Records SpecialistOmni Inclusive • Summit, NJ, United States
Quality - Quality Records Specialist

Quality - Quality Records Specialist

Omni Inclusive • Summit, NJ, United States
13 hours ago
Job type
  • Full-time
Job description

Global Supplier Quality, External QC Quality Records

Location: Summit, NJ

Purpose And Scope Of Position: The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL). Other duties may include; coordinate shipping and testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT. This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.

Required Competencies: Knowledge, Skills, and Abilities:

  • Experience with deviation and change control management, preferably with Infinity systems
  • Strong organizational skills, including ability to follow assignments through to completion
  • Ability to work in a fast paced environment, meet deadlines, and prioritize work from multiple projects
  • Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams
  • Detail oriented with demonstrated application in problem solving
  • With moderate oversight from manager, think strategically and understand global impact of decisions

Duties And Responsibilities:

  • Initiation, facilitation, and tracking of quality records
  • Provide regular communication and metrics for status of quality records
  • Effectively communicate issues, risks and proposed solutions within the organization
  • Provide communication, support, and guidance to CTLs within the QA vector and upstream material team
  • Working closely with other GSQ QC members to submit and track sample material for testing at CTL
  • Create and revise SOP
  • Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)
  • Enter data and retrieve information from Sharepoint and Smartsheet testing trackers

Working Conditions (US Only): May be required to work in office environment. Sitting, standing and computer work is required. Ability to participate in conference calls.

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Quality - Quality Records Specialist • Summit, NJ, United States

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