CTO QA Label Specialist - Katalyst Healthcares & Life Sciences
Summit, NJ 07901
About the Job
Responsibilities:
- Supports all activities for the Quality Assurance Label Control group.
- Responsible for issuing clinical and commercial in-process and final product labels for labelling 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.
- Required bachelor's degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment.
- Minimum of 1 year of relevant labelling 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 behaviours 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.
Source : Katalyst Healthcares & Life Sciences