Quality Assurance Label Specialist
1 day ago
Pay Range: $32 - $34.96/hr
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
Education and Experience:
B.S. Degree required, minimum 2 years relevant work experience
DUTIES AND 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.
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