QA CTO Label Specialist

Position Title:

QA CTO Label Specialist Work Location:

Summit West, NJ Assignment Duration:

3

Months Work Schedule:

2nd Shift , Sun-Tues(alternating Wed)- 6 pm - 6:30am

Work Arrangement:

100%

Onsite Position Summary:

The Label Operation Specialist at the S-12 Cell Therapy manufacturing facility is responsible for supporting site Label Operation 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).

Background & Context:

Label Operation 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 operations 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 Operations 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:

• Must have knowledge and experience with GMP, Quality, and compliance.
• Able to write and review technical reports with clarity and brevity.
• Requires moderate direction to complete more complex tasks.
• 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 productivity.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and addresses quality opportunities to improve efficiencies.
• Builds relationships and effectively communicates internally and externally.
• Able to produce data reports with precision.
• Able to multi-task.
• Able to support internal and health authority inspections of facility.
• Associate degree required and B.

S. Degree Preferred, minimum 2 years relevant work experience.

Working Conditions & Physical Demands:

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.

Additional Information:

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.