QA Label Specialist - Katalyst Healthcares & Life Sciences

• Supports all activities for the Quality Assurance 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.

Requirements:

• 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.

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