QA Label Control Specialist - Cell Therapy (GMP Manufacturing) 2nd shift at SOKOL GxP Services

Job DescriptionJob DescriptionSOKOL 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.RequirementsEducation & ExperienceBachelor’s degree in a scientific discipline (Biology, Chemistry, or related field) – U.S. degree required1+ years of labeling experience in a cGMP/FDA-regulated biopharma environment1+ years of Quality experience1+ years of U.S. biopharmaceutical manufacturing or QA operations experience3+ years of experience using MS Office 365 (Excel, Teams, SharePoint in project/document control settings)Technical SkillsExperience in label issuance, printing, verification, and reconciliationFamiliarity with labeling systems; Crystal Reports or BarTender preferredHands-on use of document management systems (e.g., Veeva, MasterControl, Documentum)Understanding of change control, deviations, CAPA, investigations, and quality systemsAbility to write, revise, and maintain SOPs, work instructions, and technical documentationCore CompetenciesStrong understanding of GMP, compliance, and data integrityHigh attention to detail and accuracy in all documentationAbility to recognize issues, escalate appropriately, and propose solutionsExcellent communication and customer service mindsetAbility to work independently on shift while collaborating with cross-functional teamsAbility to support internal and health authority inspections through accurate documentation and retrievalStrong time-management skills with the ability to handle multiple prioritiesAdvanced computer proficiency and comfort working within electronic systemsKey ResponsibilitiesIssue and print clinical and commercial labels for manufacturing and packagingEnsure labels meet all regulatory and internal quality requirementsCoordinate with production to support timely and accurate label availabilitySupport document accuracy, label reconciliation, and tracking activitiesMaintain and update SOPs, label control procedures, and documentationProvide training for personnel on label issuance processesSupport audits, inspections, and quality investigations as requiredParticipate in continuous improvement initiatives within Label Control and QABenefitsCompetitive 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.