**Position Overview** The QA Technical Specialist will meet quality and compliance expectations for assigned areas on time, right-first-time and implement assigned compliance improvements. **Company Overview** We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At FUJIFILM Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients. **Job Description** **MAJOR ACTIVITIES AND RESPONSIBILITIES:** + To provide compliance assessment and support to the customers for deviations, laboratory OOS investigations and change controls related to QC laboratory testing, test method and analytical instrumentation + Participates on project teams and collaborates with owners throughout the project lifecycle ensuring analytical compliance. + Works with internal departments to drive continuous improvement in the Laboratory state of compliance under limited supervision. + Reviews laboratory data, ensuring compliance to specifications. + Reviews Raw Material and Stability COAs and Reports. + Reviews method validation/stability protocols and reports, instrument qualification documents, ensuring that protocol and testing requirements align with established industry standard and internal documentation. + Serves as QA contact for QC, Analytical PD and the Clients for analytical issues. + Revises and reviews master plans, SOPs, work instructions and training course plans for analytical instrument operation, stability and analytical test methods, ensuring alignment with qualification documentation. + Serves as SME during audits for analytical issues, as needed. + Help oversee the development, implementation and maintenance of, and compliance to, department procedures and policies Skill set preferred: + Experience on plate assays + Experience on compendial monograph review + Experience on using Soft Max Pro software + Experience with chromatography + Experience reviewing Microbiological disciplines common to the laboratory include, but are not limited to: + bioburden testing (membrane filtration) + endotoxin determination (kinetic chromogenic, gel clot), + environmental and clean utility monitoring, + Gram staining, and culture purity testing The ideal candidate also has experience with automated and/or rapid microbiological methods. **Knowledge, Skills and Abilities'** + Ability to evaluate and review Environmental monitoring and other contamination control testing + Ability to review microbiological test results, including but not limited to bioburden, endotoxin, sterility and microbial identification **Minimum Education and Experience Required:** + BS/BA in Microbiology or Biology +6 years of experience or; + MS/PhD +0 years of experience + Experience supporting OOS, OOT and deviation investigations To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agenciesto any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencieswere engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agencyengagement process is hired, no fee or payment of any kind will be paid. **EEO Information** Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. **ADA Information** If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com). **Job Locations** _US-NC-Research Triangle Park_ **Posted Date** _1 day ago_ _(3/3/2025 1:01 PM)_ **_Requisition ID_** _2025-33542_ **_Category_** _Quality Assurance_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_