Quality Control Associate, Chemistry

Step into a core analytical role within a state-of-the-art pharmaceutical laboratory where your testing expertise directly ensures patient safety and therapeutic excellence. In this position, you will perform high-precision release and stability testing on advanced products using top-tier instrumentation—such as HPLC, UPLC, and Dynamic Light Scattering—while collaborating within a digitized, audit-ready GMP ecosystem. If you are looking to deepen your chromatographic troubleshooting skills, author quality investigations, and mentor emerging talent, this opportunity provides a clear pathway for professional impact and technical growth.

Operating as an individual contributor in the QC Chemistry laboratory, your main responsibilities will include:

Analytical Testing & Assays: Execute cGMP analytical chemistry testing for product release and stability programs, utilizing techniques including HPLC, UPLC, UV spectroscopy, Dynamic Light Scattering (DLS), particle analysis, pH, appearance, and osmolality.

Method & Equipment Troubleshooting: Assist with troubleshooting assay methods and complex analytical equipment; participate in investigating Out of Specification (OOS) results and non-conforming laboratory events.

Digital Systems & Data Integrity: Complete electronic assay forms, enter test results, and manage sample workflows in LIMS (LabVantage), strictly adhering to Good Documentation Practices (GDP) and data trending protocols.

Quality Systems Support: Author and review deviations, laboratory investigations, change controls, and CAPAs, contributing practical bench insight to continuous compliance.

Documentation & Technical Writing: Draft and revise Standard Operating Procedures (SOPs), test protocols, and summary reports to maintain alignment with evolving regulatory expectations.

Laboratory Operations & Mentorship: Prepare reagents, support sample and reference standard management, oversee lab supply stocking, maintain instrument readiness, and support junior analysts with training and technique troubleshooting.

Education: Technical scientific qualification (FP / Ciclo Formativo de Grado Superior in Analysis and Control / Laboratory) or Bachelor’s Degree in Chemistry, Pharmacy, or a related scientific discipline.

Experience: Minimum of 2 years of proven Quality Control laboratory experience within the pharmaceutical or biopharmaceutical industry under GMP conditions.

Hands-on Technical Skills: Solid practical experience with chromatographic systems (HPLC, UPLC), spectroscopic techniques (UV), and physical characterization methods (e.g., Dynamic Light Scattering, particle analysis).

Regulatory Knowledge: Working knowledge of FDA, EU/EMA, and ICH guidelines, accompanied by a rigorous adherence to Data Integrity and Good Documentation Practices.

Software: Experience with laboratory digital platforms, particularly LIMS (LabVantage preferred).

Languages: Minimum B2 English proficiency (able to read technical protocols, document deviations, and navigate global systems).

Shift Availability: Availability to work the afternoon shift (2:00 PM – 10:00 PM) following the initial training period.

High-Impact Science: Play a direct role in releasing critical therapies that reach patients globally under strict international standards.

Advanced Analytical Portfolio: Expand hands-on expertise across modern chromatographic, spectroscopic, and biophysical characterization platforms.

Modern Digital Laboratory: Work daily with integrated electronic assay forms and LIMS systems designed to minimize administrative friction.

Collaborative & Structured Environment: Join a stable, highly supportive laboratory team with dedicated initial training before transitioning to routine shift execution.