Biotecnologia jobs in United States

Company overview :

With over 85 years of experience, UQUIFA Group is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, serving the pharmaceutical and animal health industries worldwide. Operating under cGMP conditions, our two manufacturing sites in Spain and Mexico have been inspected and approved by leading global pharmaceutical companies and regulatory authorities, including the US FDA. Since 2018, Soneas Chemicals Ltd., a Budapest-based company focused on CDMO activities, has been part of the UQUIFA Group, enhancing our capabilities in route scouting, process optimization, and both small- and large-scale manufacturing. Our commitment to innovation, quality, safety, passion, environmental sustainability, and flexibility drives us to deliver excellence to our clients in over 70 countries.

Our plant in Sant Celoni is looking to hire a QA Compliance Auditor.

• Ensure compliance with EU GMP, FDA 21 CFR Part 210 / 211, ICH Q7, and Data Integrity (ALCOA++ principles) in manufacturing operations.
• Oversee and review GMP documentation, including Standard Operating Procedures (SOPs), batch records, and technical reports.
• Provide support to manufacturing and packaging processes to address any compliance issues.
• Own internal audits, regulatory inspections (FDA, EMA, local authorities), and customer audits. Responsible for the management of external audits of customers, internal audits, and supplier audits as part of the supplier qualification program, serving as the primary point of contact for customers and the commercial team regarding general quality issues.
• Ensure timely implementation and follow-up of CAPAs from audits and regulatory observations including preparation and review of the CAPA Plan, liaising with relevant departments to ensure improved GMP compliance.
• Own supplier qualification processes, including documentation review and compliance verification.
• Manage quality questionnaires, including creating and updating company-wide and customer-specific quality questionnaires.
• Fully own and maintain the external audit calendar.
• Organize audit agendas, escort auditors, coordinate internal staff, and communicate audit results.
• Define and update audit work procedures, as well as company presentation documentation.
• Execute internal audits / self-inspections and supplier audits in collaboration with qualified auditors.
• Prepare and / or review supplier audit reports, approve action plans (CAPA), and track their implementation until closure.
• Manage training needs within the department.
• Ensure timely delivery of documentation to clients related to activities under their responsibility.

• Fluent English and native Spanish proficiency.
• Detail-oriented with strong documentation and compliance mindset.
• Strong solution focus and ability to build and maintain relationships within the QA team and across business functions.
• Excellent business acumen with a deep understanding of organizational priorities and operational processes that drive profitable growth.
• Excellent attention to detail and ability to manage complex documentation.
• Strong problem-solving skills with the ability to initiate and implement improvements.
• High resilience and ability to adapt to a dynamic work environment.
• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related field.
• Minimum 2 years of experience in Quality Assurance, GMP Compliance, or Quality Operations in the pharmaceutical or API manufacturing industry.
• Strong understanding of GMP compliance (EU / FDA), ICH Q7 guidelines, and Data Integrity (ALCOA+ principles).

If you are looking for an opportunity to contribute to a leading API manufacturer and be part of a collaborative and innovative team, we would love to hear from you! Apply now and join UQUIFA Group in shaping the future of pharmaceutical manufacturing.