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

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.

• 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)

• Experience in
  label issuance, printing, verification, and reconciliation
• Familiarity with
  labeling systems
  ;
  Crystal Reports or Bar Tender
  preferred
• Hands-on use of
  document management systems
  (e.g., Veeva, Master Control, Documentum)
• Understanding of
  change control, deviations, CAPA, investigations, and quality systems
• Ability to write, revise, and maintain
  SOPs, work instructions, and technical documentation

• Strong understanding of
  GMP, compliance, and data integrity
• High attention to detail and accuracy in all documentation
• Ability to recognize issues, elevate 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

• 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

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.