Quality Records & Change Control Specialist

TechDigital Group; Summit (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a detail-oriented professional to manage external quality control processes. This role involves coordinating with Contract Test Laboratories and ensuring timely release of vector for various programs. The ideal candidate will have a strong background in deviation management and excellent communication skills to work cross-functionally. You will play a vital role in maintaining compliance with FDA/EMA regulations while contributing to the quality assurance of biotherapeutic products. Join a dynamic team where your expertise can make a significant impact on innovative biomanufacturing initiatives.

Qualifications

• Bachelor's degree required in relevant scientific discipline.
• Prefer 3 years' experience in biotherapeutics/biomanufacturing QC/QA.

Responsibilities

• Initiate and track quality records for external QC processes.
• Communicate issues, risks, and solutions within the organization.
• Work closely with GSQ QC members for sample testing.

Skills

Deviation and change control management

Organizational skills

Communication skills

Problem-solving

Strategic thinking

Education

Bachelor's degree in relevant scientific discipline

3 years' experience in biotherapeutics/biomanufacturing QC/QA

Tools

Infinity systems

SharePoint

Smartsheet

Job description

An established industry player is seeking a detail-oriented professional to manage external quality control processes. This role involves coordinating with Contract Test Laboratories and ensuring timely release of vector for various programs. The ideal candidate will have a strong background in deviation management and excellent communication skills to work cross-functionally. You will play a vital role in maintaining compliance with FDA/EMA regulations while contributing to the quality assurance of biotherapeutic products. Join a dynamic team where your expertise can make a significant impact on innovative biomanufacturing initiatives.