Direct message the job poster from AL Solutions
Expert in linking Commercial & C-Suite Professionals to Biotech and CDMOs throughout the United States & Europe.
About the Role:
As a QA Specialist, you will play a key role in maintaining and enhancing the Quality Management System (QMS) of our CDMO operations in Barcelona. You will ensure compliance with GMP, regulatory requirements, and internal quality standards across development and manufacturing processes for our clients in the pharmaceutical/biotech sector.
Key Responsibilities:
* Support daily QA operations including batch record review, deviation investigations, change control, and CAPA management
* Ensure compliance with GMP guidelines and applicable international regulations (EMA, FDA, ICH, etc.)
* Participate in internal and external audits (regulatory and client-based)
* Collaborate with production, QC, R&D, and regulatory affairs teams to ensure alignment on quality objectives
* Review and approve quality documentation including SOPs, validation protocols, and specifications
* Support product release activities and liaise with Qualified Persons (QPs) as needed
* Contribute to continuous improvement initiatives and risk assessments within QA
* Assist in training programs for QA procedures and GMP awareness across departments
* Support QA oversight for technology transfer and new product introductions
Qualifications:
* Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or related life science discipline
* 2+ years of experience in a QA role within a GMP-regulated environment (preferably CDMO, pharma, or biotech)
* Strong knowledge of EU GMP and understanding of FDA regulations
* Experience with QMS tools and electronic documentation systems
* Fluent in English and Spanish (both written and spoken)
* Strong communication, organization, and problem-solving skills
* Ability to work both independently and as part of a cross-functional team
Seniority level
* Seniority levelAssociate
Employment type
* Employment typeFull-time
Job function
* Job functionResearch
* IndustriesPharmaceutical Manufacturing and Biotechnology Research
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