QA Label Control Specialist - Cell Therapy (GMP Manufacturing) 2nd shift
Company: SOKOL GxP Services
Location: Summit
Posted on: February 16, 2026
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Job Description:
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 Experience in label issuance, printing,
verification, and reconciliation Familiarity with labeling systems
; Crystal Reports or BarTender preferred Hands-on use of document
management systems (e.g., Veeva, MasterControl, Documentum)
Understanding of change control, deviations, CAPA, investigations,
and quality systems Ability to write, revise, and maintain SOPs,
work instructions, and technical documentation Core Competencies
Strong understanding of GMP, compliance, and data integrity High
attention to detail and accuracy in all documentation Ability to
recognize issues, escalate appropriately, and propose solutions
Excellent communication and customer service mindset Ability to
work independently on shift while collaborating with
cross-functional teams Ability to support internal and health
authority inspections through accurate documentation and retrieval
Strong time-management skills with the ability to handle multiple
priorities Advanced computer proficiency and comfort working within
electronic systems Key Responsibilities Issue and print clinical
and commercial labels for manufacturing and packaging Ensure labels
meet all regulatory and internal quality requirements Coordinate
with production to support timely and accurate label availability
Support document accuracy, label reconciliation, and tracking
activities Maintain and update SOPs , label control procedures, and
documentation Provide training for personnel on label issuance
processes Support audits, inspections, and quality investigations
as required Participate in continuous improvement initiatives
within Label Control and QA 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.
Keywords: SOKOL GxP Services, Greenwich , QA Label Control Specialist - Cell Therapy (GMP Manufacturing) 2nd shift, Science, Research & Development , Summit, Connecticut
