Quality Assurance Associate
Just-Evotec is a forward-thinking company focused on innovation and success. They are seeking a passionate QA Associate to execute day-to-day QA responsibilities for GMP manufacturing and ensure compliance with regulatory standards. Responsibilities Review executed Manufacturing Batch Records Participate in compliance walkthrough of the Manufacturing floor and other assigned areas Partner with Manufacturing to ensure compliance in Manufacturing operations Review and approve Master Batch Records and other supporting documents Execute process performance and product quality monitoring programs Alert senior management of potential deviations or compliance risks Initiate and review all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements Provide input on communication as to the status of deliverables to customers, management, and stakeholders Assist with developing training regarding QMS process or system changes Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records) Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement Lifecycle management of the stability program for clinical and commercial products Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones Support the design of stability protocols to ensure that they are aligned with program strategy and regulatory requirements Ensure that stability studies are executed according to protocol Review, verification, disposition, and archival of stability study data for assigned programs Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution Interpretate stability results to support expiry, trending, and conditions of products Support product stability related content in regulatory submission, including responses to questions and post-marketing Skills Bachelor's Degree biological sciences, chemistry, biochemistry, engineering, or related life science field and 1 year of relevant quality experience OR Associate's degree and 3 years of relevant quality experience OR High school diploma / GED and 6 years of relevant quality experience Strong attention to detail Ability to collaborate and communicate cross-functionally Benefits Discretionary annual bonus Comprehensive benefits to include Medical, Dental and Vision Short-term and long-term disability Company paid basic life insurance 401k company match Flexible work Generous paid time off Paid holiday Wellness and transportation benefits Company Overview Evotec is a pharmaceutical and life science company that provides drug discovery and gene therapy solutions. It was founded in 1993, and is headquartered in Hamburg, Hamburg, DEU, with a workforce of 5001-10000 employees. Its website is Company H1B Sponsorship Evotec has a track record of offering H1B sponsorships, with 5 in 2025, 2 in 2023, 2 in 2022, 3 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.