Provide quality oversight of outsourced GMP operations (CMC, CDMO, contract labs). Review and approve / reject policies, batch records, test methods, and change controls. Perform lot disposition of drug substances, products, and clinical materials. Support investigations, deviations, and CAPAs to ensure compliance. Assist with regulatory audits and vendor qualifications. Present quality metrics and drive continuous improvement initiatives. Requirements: Bachelor's degree in molecular biology, biochemistry, or related field (Master's preferred). 10+ years of QA management experience in biotechnology or medical devices. Strong knowledge of cGMPs, FDA, and international regulations. Excellent communication, organization, and mentoring skills. #J-18808-Ljbffr Lumicity
Job OverviewAs a (Junior) Cloud Engineer, you will support our infrastructure team in maintaining and improving our Kubernetes-based platform hosted on AWS. You will contribute to the continuous enhancement of our cloud systems, ensuring reliability, scalability, and...
...Job Summary: We are seeking a skilled and compassionate Phlebotomist to join our healthcare team. The Phlebotomist will be... ...bonus (1yr commitment) Keywords : Entry-Level, No Experience Required, Paid Training Provided, On-the-Job Training, Career...
...Conflicts Researcher We are always seeking talented, motivated, growth-minded, and creative individuals. Our firm is committed to providing... ...regarding conflicts of interest and trends/changes in the legal industry. Knowledge, Skills, and Abilities: Ability to compile...
...motivation and resilience, able to find paths forward and drive execution in an uncertain environment. ~ Able to work in both Chinese and English (listening, speaking, reading and writing) . ~ Bachelors degree or above; majors in Finance, Economics,...
...Documentation: Maintain accurate patient records and ensure compliance with coding and billing regulations. Team Collaboration: Work with... ..., backed by a supportive team of physicians (often remote but always accessible), nurses, and first responders who value your...