Principal Associate QA - Labeling and Packaging

Job Position Overview

The Labeling and Packaging Quality Assurance Associate provides quality oversight for labeling, packaging, ultra-low temperature storage, and distribution operations at the LP2 Advanced Therapies site. This position supports the start-up of labeling and packaging capability for new drug products, provides real-time quality support on the manufacturing floor during operations, and supports validation of labeling and packaging for multiple new ultra-low temperature products. The role partners with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and external partners to ensure labeling and packaging operations meet cGMP requirements and regulatory commitments. This position also provides white-glove, end-user support for post-distribution activities to ensure patient needs are met.

Responsibilities

• Lead quality assurance support for the start-up of labeling and packaging operations for new drug products, including process mapping, procedure and batch record development, artwork and label proof approval, and first GMP execution.
• Provide on-the-floor quality oversight during labeling and packaging operations, including line clearance, label reconciliation, in-process checks, batch record review, and real-time resolution of floor questions.
• Support validation of labeling and packaging for multiple new ultra-low temperature drug products, including protocol development, execution, and reporting for equipment qualification, and PPQ activities.
• Provide quality support for storage and distribution of drug product, including ultra-low temperature and cryogenic storage, cold-chain excursion review, shipping lane and container qualification, and release-to-ship processes. Provide white-glove, end-user support for post-distribution activities to ensure patient needs are met.
• Initiate and investigate deviations, change controls, and CAPAs associated with labeling, packaging, storage, and distribution, and maintain inspection readiness of the area as a subject matter expert.

Additional Skills / Preferences

• Previous experience in pharmaceutical labeling and packaging operations, including line clearance, label reconciliation, and serialization.
• Previous experience with cell therapy, gene therapy, vaccine, or other products requiring ultra-low temperature or cryogenic handling and cold-chain distribution.
• Prior work with new product introduction, technology transfer, or start-up of a new manufacturing capability.
• Proven ability to author and execute validation protocols (IQ/OQ/PQ, EMPQ, PPQ) and temperature mapping studies.
• Proficient in electronic quality and manufacturing systems, including Veeva Vault, Kneat, MES/electronic batch records, and LIMS.
• Proven ability to make risk-based quality decisions in real time and to escalate issues clearly under schedule pressure.

Additional Information

• Travel Percentage (%): Up to 15%
• Shift Information: Day shift, with off-shift and weekend support required during packaging campaigns, validation runs, and start-up activities. The position is on-site and requires regular presence on the manufacturing floor and in cold-chain warehouse areas.