Quality Records Specialist in Summit, NJ

100% onsite required

• Initiating and managing deviations and change controls in quality systems
• 1+ years in QA
• Create and revise SOP
• Minimum Associate degree or preferred Bachelors in relevant scientific discipline.

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 testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a Client 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

DESIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
• Experience within the Cellular Therapeutics and/or gene-based products.
• Experience with biologics will be considered.
• Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management
• Knowledge of applicable FDA/EMA regulations in the biotechnology industry
• Experience managing external suppliers and other supply chain issues
• Experience with Quality Systems (change control, deviation and investigation)

Education and Experience:

• Preferred Bachelors in relevant scientific discipline, or 3 years’ experience in biotherapeutics/biomanufacturing QC/QA

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

Other duties may include:

• 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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