Summary
The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the client site, including the coordination, issuance, reconciliation, and management of production labels and records. To succeed in this role, you will have a strong attention to detail and an analytical mindset.
Education:
Bachelors degree or equivalent
Experience Basic Qualifications:
1 year of relevant labeling experience in a cGMP/FDA regulated environment
• Some document management experience
• Crystal reports experience preferred
• Strong communication and customer service skills.
• Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
• Develop and improve label issuance processes to drive operational efficiency
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
• Possess project management skills.
• Experience interacting with FDA or other regulatory agencies strongly preferred
• Strong knowledge of cGMPs and domestic regulatory requirements
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
• Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network
DUTIES AND RESPONSIBILITIES:
• 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.
QA CTO Label Specialist • Summit, NJ
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