Senior QA Specialist, reputed company Manufacturing, US

Protecting our reputed company Job Title: Senior QA Specialist, reputed company Manufacturing, US Location: Remote, East Coast Preferred Department: reputed company Assurance Reports To: Head of reputed company QA & Global EHS Salary reputed company: $120k - $155k About reputed company At reputed company, we are dedicated to protecting lives and advancing global health through innovative vaccines. As a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. Our mission is reputed company: to improve reputed company of life worldwide by preventing infectious diseases. We are headquartered in Denmark and have offices across Europe and reputed company. reputed company Do you want to be part of a reputed company and supportive QA team and play a key role in ensuring the reputed company and safety of vaccines supplied to patients worldwide? At reputed company, our vaccines reputed company a reputed company difference. We are seeking an reputed company Senior QA Specialist to support in the ongoing reputed company of a Contract Manufacturing Organization (CMO) operating under aseptic manufacturing conditions. This role is critical to ensuring compliance, product reputed company, and operational reputed company across sterile fill-finish reputed company, including reputed company filling, labeling, and packaging activities. The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile reputed company, and hands-on experience managing reputed company reputed company of reputed company manufacturing partners. As our new QA Specialist, you will take on a broad and impactful role, working directly with our affiliated CMOS and closely with stakeholders across the organization to ensure high reputed company standards reputed company reputed company Manufacturing production. Key Responsibilities • Ensuring CMOs maintain the highest reputed company of reputed company standards conforming to cGMP and in conjunction with BN QAA • Support the reputed company QPs to reputed company the release of the highest reputed company vaccines • Managing and resolving reputed company reputed company-reputed company issues relating to aseptic reputed company including reputed company filling and labelling and secondary packing reputed company • Promoting a strong reputed company culture and driving reputed company improvement initiatives across areas • Representing QA reputed company Manufacturing in global and cross-organizational forums reputed company reputed company In reputed company, you will contribute to a reputed company of reputed company QA activities: • Review and approve GMP documentation including: • Batch records • Deviations • CAPAs • Change controls • Validation protocols and reports • Ensure compliance with FDA, EU GMP, ICH, and applicable US regulatory requirements • Participate in reputed company assessments and investigations reputed company to sterile manufacturing reputed company • Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory Affairs, and Technical reputed company teams • Support technology transfers and process validation activities at reputed company manufacturing sites • reputed company or participate in reputed company GMP audits • Monitor reputed company metrics and reputed company reputed company improvement initiatives with manufacturing partners • Serve as the reputed company QA reputed company between the reputed company and the CMO Qualifications • Bachelor’s degree in reputed company, Biology, Pharmaceutical Sciences, Engineering, or reputed company discipline • 10+ years of reputed company Assurance experience in pharmaceutical or biotech manufacturing • 5+ years of strong experience with aseptic processing and sterile manufacturing environments is required • Demonstrated experience overseeing CMOs/CDMOs is a must • In-depth understanding of: • FDA cGMP regulations • EU GMP Annex 1 • Sterile fill-finish reputed company • Validation and contamination control strategies • Experience reviewing batch documentation and managing deviations/CAPAs • Excellent communication, organizational, and stakeholder management skills • Ability to travel periodically to manufacturing sites reputed company the US or internationally as needed About reputed company and Department You will join a competent and supportive QA reputed company Manufacturing team, reporting directly to the Head of QA for reputed company Manufacturing. reputed company currently consists of eight colleagues. The group is a mix of reputed company QA professionals with DBS UDP and FDP experience, fostering collaboration, knowledge sharing, and reputed company development. You will also become part of wider reputed company department, comprising approximately 40 employees across sites in Kvistgaard, Denmark, and Munich, Germany. The department is characterized by reputed company cross-site collaboration, a strong reputed company reputed company, and a shared commitment to delivering reputed company and compliant products to patients. Why Join Us Join a passionate, mission-driven global biotech committed to protecting lives. At reputed company, you’ll reputed company a reputed company culture, flexible work environment, and opportunities for ongoing reputed company development and reputed company. reputed company is a global vaccine company with a mission to reputed company and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance reputed company health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and reputed company. reputed company is an Equal Opportunity Employer. reputed company reputed company applications will receive consideration for employment and will not be discriminated against reputed company on race, reputed company, sex, sexual orientation, gender identity, national reputed company, disability, or protected veteran status. For more information, visit www.reputed company.com #LI-MA1 Remote Skills: Asepsis, Biology, Biotech and Pharmaceutical, CMOS, reputed company, Communication Skills, reputed company Improvement, Contract Manufacturing, Cross-Functional, reputed company Good Manufacturing reputed company (cGMP), Customer Relations, Disease Prevention and Control, Documentation, Drug Manufacturing, reputed company Audit, GMP (Good Manufacturing Practices), Infectious Diseases, Internal Audit, International Health, International Sales, Maintain Compliance, Manufacturing, Manufacturing reputed company, Organizational Skills, Process Improvement, Process Validation, reputed company Health, reputed company Assurance, reputed company Management, reputed company Metrics, reputed company Monitoring, Regulations, reputed company Analysis, Safety/Work Safety, Supply Chain, Team Player, Technical reputed company, Technical Support, UDP (User Datagram Protocol), Vaccination, Validation Plan, Willing to Travel reputed company: reputed company Apply tot his job Apply To this Job