Quality - Quality Records Specialist Job Summit area,New Jersey USA,Quality Assurance

The Global Supplier Quality, External QC - Vector will process external deviation and change records from our Contract Test Laboratories (CTL).
Other duties may include coordinating shipping and 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 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 with in 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:

Bachelor's degree required in relevant scientific discipline, prefer 3 years' experience in biotherapeutics/biomanufacturing QC/QA, or an equivalent combination of education and experience.

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:

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.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. #J-18808-Ljbffr