Quality Control Associate, Laboratory Equipment Qualificatio

Step into a pivotal quality control role where hands-on laboratory discipline meets modern digital transformation. Supporting an advanced analytical environment, you will bridge the gap between rigorous equipment qualification, controlled-temperature operations, and end-to-end sample lifecycle management. If you are eager to bring your GMP expertise into an ecosystem actively deploying modern LIMS architectures and exploring the compliant integration of Generative AI tools to optimize laboratory throughput, this position offers an ideal platform to make a tangible impact on cutting-edge medicines.

Operating as an individual contributor in close collaboration with internal testing groups, external laboratories, Quality Assurance, digital teams, and CMO facilities, your key responsibilities will include:

Equipment & Temperature Unit Management: Coordinate, monitor, and support the qualification, routine maintenance, and operational troubleshooting of controlled-temperature units (freezers, incubators, walk-in chambers) and related laboratory systems to ensure continuous compliance and sample safety.

End-to-End Sample Lifecycle Control: Oversee the receipt, custody, storage, inventory tracking, reconciliation, transfer, and disposition of Chemistry, Microbiology, and Bioassay samples across internal and partner facilities under strict GMP, GDP, and Data Integrity regulations.

Stability Program Execution: Own the routine lifecycle of stability samples according to approved protocols, executing scheduled pull-outs with precision and arranging safe, on-time handover to analytical testing benches.

Cross-Functional & Partner Alignment: Act as the operational liaison between internal testing labs, client sites, external testing partners, and CMOs to harmonize testing timelines, technical requirements, and prioritization.

Quality Systems Support: Actively contribute operational insights to laboratory investigations, root-cause analyses, deviations, change controls, and CAPAs.

Digital Workflows & Innovation: Partner with digital teams to streamline LIMS operations and explore the responsible application of emerging Generative AI capabilities for knowledge management, workflow optimization, and daily decision support.

Inspection Readiness & Lab Housekeeping: Maintain an organized, collaborative, and audit-ready laboratory environment, ensuring all requalifications and mandatory trainings are completed on schedule.

Education: Technical scientific diploma (FP / Ciclo Formativo de Grado Superior) or Bachelor’s Degree in Chemistry, Biology, Pharmacy, or a related scientific field.

Experience: Minimum 2 years of proven QC laboratory experience in the pharmaceutical or biopharmaceutical industry, operating under strict GMP regulations.

Technical & Regulatory Expertise: Familiarity with laboratory equipment/chamber qualification, temperature monitoring, and stability lifecycle workflows. Working knowledge of FDA, EU/EMA, and ICH guidelines alongside strong Data Integrity standards.

Languages: Minimum B2 English proficiency (capable of managing technical documentation and cross-border stakeholder communication).

Key Mindsets: Proactive ownership mentality, multitasking capabilities, solid communication skills, and an enthusiasm for digital workflow optimization.

Work Arrangement: 100% onsite availability to ensure hands-on equipment oversight and seamless physical laboratory collaboration.

Pioneering Scientific Mission: Play a direct role in safeguarding and accelerating advanced treatments destined for patients globally.

Exposure to Next-Gen Digital Quality: Combine traditional GMP bench precision with cutting-edge digital initiatives, including advanced LIMS workflows and compliant Generative AI applications.

Cross-Functional Visibility: Engage continuously with multidisciplinary groups, external testing hubs, CMO networks, and enterprise technology units.

Engaging Onsite Collaborative Culture: A 100% in-person working model designed to promote real-time technical problem solving, direct mentorship, and tight-knit team collaboration.