Quality Specialist

2 weeks ago

Summit, United States Aequor Inc 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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