Quality Specialist

2 months ago


Summit, United States Aequor Full time

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


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