Position Title: QA CTO Label Specialist
Work Location: 100% onsite
Assignment Duration: 06 Months
Work Schedule: Sun-Wed (6:30 am - 4:30 pm)
Work Arrangement: 100% onsite

Position 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 BMS 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 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 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.

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; 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

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $32.00/hr.