Quality Assurance || Pharma background

Must Haves: deviations, CAPA, SOP writing, Project Management, Pharma background.

Job Description:
The Quality Assurance Label Control (QALC) Labeling 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.

Experience Basic Qualifications:

Minimum of 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.

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