Quality - Quality Records Specialist

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.