Hiring: QA Specialist, Validation Company: FUJIFILM Biotechnologies Location: Holly Springs, NC Job Posted Time: 2026-09-10 13:35:13 Target Skills & Keywords : Change Management, Quality Assurance, Risk Management About the job Experience: •1-3 years of experience working in a GMP regulated environment. •3 years of experience working in a GMP regulated environment. Required Skills: •Performs a role within the QA team for the development of documents, processes, and procedures for the Validation program. •Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state. •Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports. •Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities and equipment. •Generates, reviews, and approves QA documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility. •Ensures project and operational quality objectives are met within desired timelines. •Manufacturing (Clean Room) shop floor support for issue resolution, as needed. •Participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections. Qualifications: •Strong verbal and written communication skills to partner with different teams and stakeholders. •Excellent oral and written communications skills and fluency in English. •Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks. •Demonstrated capacity to think critically and have superior problem-solving skills. •Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals. •Basic knowledge and application of cGMP compliance and other related regulations. •Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment. •Occasional opportunity for International and/or Domestic travel may be available. •Bachelor’s degree in Life Sciences or Engineering with 2 years of applicable industry experience; OR, Master’s degree in Life Sciences or Engineering with no previous experience. •Working knowledge and experience with ASTM E2500, Smartsheets, Trackwise, Veeva, and Kneat validation software. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!