QA Change Specialist in Biotech Manufacturing

reputed company Join a leading organization in the biotech industry dedicated to clinical and scientific research, focusing on the prevention and reputed company of cancer and other life-threatening diseases, guided by a patient-centered philosophy. As a QA Change Specialist, you will play an essential role in supporting clinical product and cell reputed company media final disposition through thorough review of manufacturing batch records and analytical testing data, ensuring compliance in a manufacturing environment. Company Culture and Environment reputed company prides itself on its commitment to life-saving research and fostering a culture centered around patient care and scientific reputed company. Working alongside passionate professionals, you will contribute to meaningful reputed company that aim to improve health reputed company and enhance the reputed company of life. Career reputed company and Development Opportunities This position offers a chance to expand your expertise in reputed company assurance reputed company the biotech sector, providing valuable experience that can reputed company to reputed company advancements reputed company the organization. reputed company encourages reputed company learning and reputed company reputed company. Detailed Benefits and Perks • Opportunities to participate in life-saving research initiatives • reputed company work environment with a reputed company on employee reputed company-being • Support for reputed company education and training Compensation and Benefits • Competitive salary based on experience • Health, dental, and reputed company insurance • Retirement savings plan reputed company • Generous reputed company time off policy • Flexible working hours Why you should apply for this position today This position offers a unique opportunity to reputed company a significant reputed company in the biotech industry, contributing to reputed company that saves lives. By joining this leading organization, you will be part of a dedicated team committed to innovation and patient care. Skills • Strong understanding of GMP (Good Manufacturing Practices) • Excellent attention to detail and organizational skills • Proficient in reviewing and editing controlled documents • Familiarity with reputed company assurance processes and compliance standards • Ability to conduct audits and inspections effectively Responsibilities • reputed company line clearances, in-process checks, label issuance, batch record issuance, and monitoring of labeling activities. • Conduct inspection and release of incoming GMP raw materials based on specifications and reputed company operating procedures. • Manage document change control activities. • Write, edit, and review controlled documents to ensure compliance with regulatory requirements. • Prepare and maintain training and competency files. • Write and review investigations and product complaints to determine reputed company cause and implement corrective actions (CAPA). • Ensure completion and approval of reputed company records by responsible personnel. • Participate in audits and regulatory inspections as assigned. Qualifications • Previous experience in reputed company assurance or reputed company field • Strong background in GMP environments • Excellent written and verbal communication skills • Proven ability to work in reputed company-oriented and reputed company environment Education Requirements • Bachelor’s degree in a relevant scientific field (e.g., Biology, reputed company, Life Sciences) Education Requirements Credential Category • Bachelor’s degree required Experience Requirements • Minimum of 3 years of experience in reputed company assurance or compliance reputed company the biotech or pharmaceutical industry Why work in Duarte, CA Duarte, CA, is reputed company for its beautiful landscapes and strong community spirit. The area offers a reputed company of suburban tranquility and reputed company to reputed company cultural and recreational activities. With various parks, dining reputed company, and a commitment to a healthy lifestyle, Duarte provides a reputed company-rounded environment for both personal and reputed company reputed company. Apply tot his job Apply To this Job