Position Title: QA CTO Label Specialist

Work Location: US – NJ – Summit West, S12

Assignment Duration: 6 months

Work Schedule: 2nd Shift, Sun–Wed, 4:00 PM–2:00 AM

Work Arrangement: 100% onsite

Position Summary:

The Label Control Specialist at the client's manufacturing facility is responsible for supporting site Label Control activities at S-12 in accordance with 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.

Key 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 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.

Qualification & Experience:

Required Competencies (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.
Requires moderate direction for complex tasks; routine tasks are done independently.
Must be time-organized and possess an independent mindset.
Good understanding of electronic document management and manufacturing execution systems.
Has advanced computer skills to improve productivity.
Confident in decision-making for non-routine issues.
Recognizes and improves quality process opportunities.
Proposes solutions for complex issues; works with management for resolution.
Follows established procedures and performs assigned work.
Builds relationships and communicates effectively across teams.
Recognizes conflict and proposes resolutions.
Prepares written communication and problem reports accurately.
Produces precise data reports and can multi-task.
Supports internal and health authority inspections of the facility.

Work experience placement, Afternoon shift,