Job Description

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:

• B.S. Degree required, minimum 2 years relevant work 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.

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