Overview
Quality Assurance Specialist
We are seeking a detail-oriented Quality Control Analyst to join our team in Sant Quirze del Vallès. As a key member of the laboratory, you will be responsible for ensuring the quality of raw materials, intermediates, and finished products.
Responsibilities
- Perform routine and non-routine physicochemical analyses using techniques such as HPLC (High-Performance Liquid Chromatography), Karl Fischer titration (moisture determination), FTIR / IR (identification of materials), Loss on Drying (LOD), Potentiometric titrations, Residue on Ignition (ROI), pH, conductivity, osmolality, TOC, etc.
- Carry out sampling and analysis of water systems, including : Water for Injection (WFI).
- Support environmental monitoring activities, including surface and air sampling in classified areas.
- Ensure strict adherence to GMP and ALCOA++ data integrity principles, maintaining complete, accurate, and traceable documentation.
- Document all activities clearly and contemporaneously in lab notebooks, logbooks, or electronic systems (e.g., LIMS).
- Participate in quality system activities, such as investigation of OOS / OOT results reporting of deviations and support in CAPA implementation.
- Maintain and calibrate laboratory equipment, performing routine checks and informing of any malfunction or need for maintenance.
- Follow safety protocols and contribute to keeping the lab in a clean condition at all times.
- Collaborate with cross-functional teams, including QA, production, and validation, when needed.
Requirements
Advanced Training in Laboratory Analysis and Control with 2–5 years of experience in Quality Control in a regulated environment.Practical experience in physicochemical testing including HPLC, Karl Fischer, IR, Loss on Drying, potentiometric titrations, and Residue on Ignition.Skilled in sampling and analysis of pharmaceutical water systems (WFI, Purified Water) following USP / EP methods.Familiarity with environmental monitoring in cleanroom environments is an asset.Strong knowledge of ALCOA++ principles and documentation practices.Experience with quality systems (OOS, deviations, CAPAs, change control).Proactive team player with good organizational skills and the ability to work independently.Fluent in English language (reading / writing preferred).What We Offer
Our company offers a dynamic and challenging work environment where you can grow professionally and personally. You will have the opportunity to work with experienced professionals and be part of a team that values innovation, teamwork, and continuous improvement.
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