QA CTO Label Specialist

Job Description

Job Summary:

• The Quality Assurance Label Control (QALC) Labelling Specialist supports the cGMP Label 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.

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.

Education:

• Required Bachelor’s degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment.

Experience Basic Qualifications:

• 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.
• 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 cGMP 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.

Working Conditions:

• Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.
• Weekend and off-shift support may be required.
• Occasional lifting of heavy weights up to 25 to 35 lbs.