QA Specialist (QC Laboratory)
hace 2 días
Noáin
We are looking for a QA Specialist (QC Laboratory) to join our Quality Assurance Team. As QA Specialist (QC Laboratory) , your responsibilities will include: • Act as the Quality Assurance representative within the Quality Control laboratory, ensuring compliance with GMP regulations and quality standards., • Provide active QA on-the-floor support, ensuring immediate quality guidance and promoting GMP and documentation best practices across laboratory activities., • Perform critical review of analytical documentation, laboratory records, calculations, chromatograms, integrations, analytical results and raw data., • Ensure Data Integrity compliance following ALCOA+/ALCOA++ principles, guaranteeing traceability, reliability, availability and integrity of both electronic and paper-based records., • Oversee GMP-compliant use of laboratory computerized systems and equipment, including LIMS, Empower 3, Gen 5 and other analytical platforms., • Review user access management, audit trails, backups and data archival processes whenever applicable., • Participate in deviation investigations, root cause analysis, impact assessments and CAPA definition, implementation and effectiveness verification., • Prepare, review and improve SOPs related to Quality Control, Data Integrity, raw data management, computerized systems and audit trail reviews., • Support the qualification and training of laboratory personnel in GMP requirements, Data Integrity principles and Good Documentation Practices., • Support analytical method validation and transfer activities, ensuring compliance with applicable regulatory requirements., • Collaborate closely with QC, QA, IT, Validation and other cross‑functional departments to maintain a culture of quality and continuous improvement., • Bachelor’s degree in Chemistry, Biotechnology, Biology, Biochemistry, Pharmacy or other related scientific discipline., • Minimum 4 years of experience in QA, QC or equivalent roles within a GMP-regulated pharmaceutical or biotechnology environment., • Proven experience in raw data review, analytical results verification, deviation investigations, CAPA management and GMP documentation., • Strong knowledge of GMP requirements, Good Documentation Practices and Data Integrity principles., • Working knowledge of EU GMP Annex 11, FDA 21 CFR Part 11 and GAMP 5 regulations., • Experience with laboratory computerized systems such as LIMS, Empower 3 and/or Gen 5., • Knowledge of analytical techniques including HPLC, UPLC, UV, IR, ELISA and microbiological/biological methods., • Experience in analytical method transfer and validation activities will be highly valued., • Master’s degree or postgraduate qualification in Quality, Pharmaceutical Industry, Computerized Systems Validation (CSV) or Data Integrity will be considered an asset., • Spanish fluent and English B2/C1 level, with the ability to review GMP documentation in English., • Previous experience in biotechnology/CDMO environments working with recombinant proteins, monoclonal antibodies, biosimilars, ADCs or other biologics will be highly valued., • You will have 26 paid days off: 23 vacation days + 2 personal days + 1 day off set by the company., • Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income tax (childcare, health insurance, training, etc.)., • Company benefits club, which allows 3P employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, Fnac, Rituals, El Corte Inéls, etc.)., • Flexible working hours during the week and a reduce work day on Friday of 7h., • Special Summer working day of 7h during July and August., • 3PBio is committed to the continuous, updated and personalized improvement of our personnel’s learning. To this end, we have Learning & Development department, who is in charge of creating personalized, individualized and differentiating career plans for our employees., • The company continues to focus on internal talent and stable employment, focusing on upskilling and reskilling. We offer opportunities for professional growth and take an environment of trust., • We encourage the participation of our employees in solidarity events such as charity races, social donations..., • We have several programs aimed at improving the physical, psychological and emotional well-being of our employees. In this context, we participate in the Corporate Challenge, promote healthy lunches and comfortable and safe work spaces., • We have a high-impact work environment with flat hierarchies and short decision‑making processes., • All new hires who reside outside of Navarra are provided with a relocation service and/or assistance. We know it takes people with passion and a shared purpose to manufacture advanced medicines. We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems. We are with you on your biologics journey, growing with you and supporting you with process and analytical development, preclinical and clinical supply, and commercial production. With a focus on biotechnology applications in both human an animal health sectors, we offer customized solutions that meet the specific needs of all our clients From development to product delivery, we are with you on your biologics journey. We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies. We have what it takes to help you improve lives. #J-18808-Ljbffr
