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

SOKOL GxP Services is looking for a junior level Label Control Specialist to work 100% on-site at the client's Cell Therapy manufacturing facility in Summit, NJ .

Label Control Specialist will be responsible for supporting site Label Control activities in accordance with client's policies, standards, procedures and global cGMPs.

Functional responsibilities include performing in process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).

Label Control organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives. This organization supports the facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

Estimated start date - March 2, 2026.

DUTIES AND RESPONSIBILITIES:

• Supports all activities for the Label Control group.
• Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
• Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
• Coordinates with production teams to ensure timely issuance of labels.
• Performs training of label control and issuance requirements for internal personnel as needed.
• Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
• Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
• Provides support during internal and health authority inspections and audits of facility.
• Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
• Performs supplemental investigations/projects as required by Management.
• Maintains knowledge of current GMPs and regulatory guidelines.

WORK SCHEDULE:

Second Shift

Sunday - Wednesday 3:30pm - 2:00am ( before March 29)

Sunday - Wednesday 6:00pm - 6:30pm ( starting March 29).

Important:

Attendance is crucial. Supporting 7 days/24 hours operations, including holidays and weekends.

Requirements

Education & Experience

• Required minimum: Associate's Degree; preferred - B.S;
• Required minimum: 2 years of relevant work experience;
• 1+ years of labeling experience in a cGMP/FDA -regulated biopharma environment;
• 1+ years of Quality Assurance (QA) experience;
• 3+ years of experience using MS Office 365(Excel, Teams, SharePoint in project/document control settings);
• Crystal reports and BarTender experience preferred;
• Strong communication and customer service skills.
• Must have knowledge and experience with GMP, Quality, and compliance.
• Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.
• Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.
• Must be time organized and possess an independent mindset.
• Good understanding of electronic document management and manufacturing execution systems.
• Has advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.
• Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.

Benefits

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

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.