QA Label Control Specialist - Cell Therapy (GMP Manufacturing) 2nd shift

Job Description

Job Description

SOKOL GxP Services is seeking a QA Label Control Specialist (2nd Shift) to support our client’s Cell Therapy Manufacturing facility in Summit, NJ. In this role, you will execute label control, issuance, and printing activities to ensure compliance with FDA, cGMP, and internal quality standards for clinical and commercial cell therapy products.

You will be responsible for preparing, verifying, and issuing in-process and final product labels , maintaining documentation accuracy, and supporting inspection readiness. This position collaborates closely with Manufacturing, Quality Assurance, Quality Control, and CTDO operations to ensure timely label delivery and error-free execution of GMP processes.

This is an excellent opportunity for someone with hands-on labeling experience in a regulated biopharmaceutical environment , strong documentation discipline, and the ability to work independently on a fast-paced shift supporting patient-critical therapies.

Requirements

Education & Experience

• Bachelor’s degree in a scientific discipline (Biology, Chemistry, or related field) – U.S. degree required
• 1+ years of labeling experience in a cGMP / FDA-regulated biopharma environment
• 1+ years of Quality experience
• 1+ years of U.S. biopharmaceutical manufacturing or QA operations experience
• 3+ years of experience using MS Office 365 (Excel, Teams, SharePoint in project / document control settings)

Technical Skills

Core Competencies

Key Responsibilities

Benefits

Competitive hourly rate : $27.52 – $34.96 / hr (W-2 only, no C2C).

Working Hours : 2nd Shift , Wed-Sat - 4pm-2am .

6-month contract with possibility of extension or conversion for the right candidate depending on performance.

Health insurance, holiday pay, 401(k) program, and other benefits.

Employee referral bonus program.