QA Specialist

Responsibilities Review executed batch records and supporting documentation for completeness, accuracy, and compliance Support product release activities and ensure adherence to cGMP, GDP, and ALCOA+ principles Review deviations impacting batch quality and assist with CAPA activities Maintain quality documentation and support audit and inspection readiness Identify process improvement opportunities and contribute to quality initiatives Qualifications Bachelor's degree in a scientific discipline preferred (or equivalent experience) 2+ years of QA experience in a GMP-regulated environment Experience reviewing batch records and supporting product release activities Working knowledge of FDA, EMA, and cGMP requirements Familiarity with quality systems including Deviations, CAPA, Change Control, and Document Control Strong attention to detail, organizational skills, and documentation practices Ideal Candidate Experience in pharmaceutical, biotechnology, manufacturing, or other regulated industries Strong understanding of quality systems and compliance requirements Ability to work independently and manage priorities effectively Commitment to quality, integrity, and continuous improvement #J-18808-Ljbffr