Quality Records Specialist

Job Title : Quality Records Specialist

Duration : 12 Month Contract (Possible extension based on work performance)

Location : Summit, NJ 07901

Onsite Position

Work Schedule : Mon - Fri, Business Hours

ABOUT ROLE : Must Haves :

• 1+ years in Cell Therapy
• 1+ years in biomanufacturing
• 1+ years in biotherapeutics
• 1+ years in QA / QC

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 :

DESIRED COMPETENCIES : Knowledge, Skills, and Abilities :

Education and Experience :

Preferred Bachelors in relevant scientific discipline, or 3 years' experience in bio therapeutics / bio manufacturing QC / QA

DUTIES AND RESPONSIBILITIES :

WORKING CONDITIONS (US Only) :

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.