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QA CTO Label Specialist

Careers Integrated Resources Inc Summit, NJ (Onsite) Contractor
Job Title: QA CTO Label Specialist
Job Location: Summit, NJ 100% onsite position
Job Duration: 6 Months (possibility of extension)
Shift: Sunday - Wednesday, 6:30am - 4:30pm
Payrate: $33.96 - $34.96/ hr on w2

Job Summary:
  • The Label Control Specialist at the S-12 Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at S-12 in accordance with Client 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 S-12 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
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.
Education and Experience:
  • B.S. Degree required, minimum 2 years relevant work experience.
Knowledge, Skills, and Abilities:
  • 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.
  • Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross functional teams.
  • Represents department in internal and external cross-functional teams.
  • Contributes to goals within the work group.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to produce data reports with precision.
  • Able to multi-task.
  • Able to support internal and health authority inspections of facility.
Working Conditions:
  • Work is performed in a typical office environment, with standard office equipment available and used.
  • Work is generally performed seated but may require standing and walking for up to 10% of the time.
  • Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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Job Snapshot

Employee Type

Contractor

Location

Summit, NJ (Onsite)

Job Type

QA - Quality Control

Experience

Not Specified

Date Posted

07/08/2025

Job ID

25-51056

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