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.
Job Tags
Work experience placement, Afternoon shift,