Quality Specialist

Position : Quality Records Specialist 59670- 1

Location : Summit NJ 07901

Duration : 12+ months (possibility of extension for the right candidate depending on performance)

Pay rate : $30 / hour on W2

100% onsite required

Work schedule : Mon- Fri(normal business hours)

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 compiling 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 vectors 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 the 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 the manager, think strategically and understand the 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 product 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 Bachelor's in a 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 the 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 an office environment.
• Sitting, standing, and computer work is required.
• Ability to participate in conference calls
13 days ago