Senior Quality Assurance Specialist

Job Title: Quality Assurance SpecialistJob DescriptionResponsibilities:Process GMP documentation through the electronic document management system ensuring version control, traceable editing, and adequate formatting.Route documents for review and approval, ensuring that approved templates/formats are maintained and consistent across departments.Categorize, scan, file, and retrieve GMP documents as per internal procedures.Assign and maintain unique alphanumeric coding and version control of GMP documentation.Provide assistance during cGMP compliance inspections by regulatory bodies.Prepare and issue logbooks, effective batch records, protocols, and final reports.Ensure compliant retention of GMP documentation and timely scanning of site-required documents.Work on complex problems requiring in-depth analysis and judgment.Maintain workspace cleanliness and adhere to safety rules.Hard SkillsAdvanced Knowledge of Electronic Documentation Control: Proficient in managing electronic documentation systems and ensuring compliance with regulatory standards.cGMP Regulations Expertise: In-depth understanding of cGMP regulations, FDA, and ICH guidelines related to aseptic manufacturing operations.Technical Proficiency: Highly skilled in Microsoft Office Suite (Word, Excel, PowerPoint, Project).Soft SkillsInterpersonal Skills: Strong ability to communicate effectively, both orally and in writing, with managers, customers, and employees.Organizational Skills: Effective time management, ability to multi-task, and prioritize assignments.Job TypeThis is a contract position with a duration of 6 Month(s).Work SiteThis is a fully on-site position in Irvine, California.Work EnvironmentTeam-Oriented: Emphasis on teamwork and effective communication to ensure all departments adhere to compliance standards.Detail-Oriented: High attention to detail is crucial for maintaining accurate and compliant documentation.Fast-Paced: The environment can be fast-paced, especially during audits or regulatory inspections.Safety-Conscious: Adherence to safety protocols and practices is essential, particularly when working in or around laboratory and production areas.About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.