Senior QA Analyst

Position Overview

Senior QA Analysts for FUJIFILM Diosynth Biotechnologies Texas LLC College Station TX.

Responsible for review and/or approval of basic and technical documentation drafting and reviewing internal Quality policies and procedures performing product related activities performing Quality audit functions performing product release activities identifying process and Quality System improvements and acting as a QA liaison internally and externally for drug biologics or vaccine products. Provide daily guidance work prioritization and support to other departments such as manufacturing or QC in absence of or in conjunction with their manager. Review and/or approve basic and technical documentation with minimal supervisory oversight to include but not limited to: Standard Operating Procedures; Batch Production Records (completed and approval); Commissioning qualification and validation protocols and reports; Deviation Reports; Corrective Action/Preventive Action Plans; Technical data review and approval; QC data review and approval; Drug Substance/Product Reports; and Trending QA data. Draft and review internal Quality policies procedures and reports. Perform inspection of final product containers and review and/or approval of executed process production batch records and data. Perform Quality audit functions to include but not limited to: Audit of lab notebooks; Audit of equipment logbooks; Review of vendor supplier contract laboratory audit questionnaires; and Lead vendor supplier contract laboratory and client audits. Identify process and Quality System improvement opportunities. Provide daily guidance for the compliance of the QA department to national and international standards and regulations. Support Regulatory client and internal audits. Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups; Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. Assist with technical oversight/training for the QA team and compliance related functions.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

From developing the next vaccine to advancing cell and gene therapies we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station Texas which combines a small-town feel with vibrant culture top-notch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Requirements:

Masters degree in Project Management Biology Chemistry or related biology/pharmaceutical/engineering field and three years of experience as a QA Analyst or related occupation in quality assurance OR Bachelors degree in Project Management Biology Chemistry or related biology/pharmaceutical/engineering field and five of experience as a QA Analyst or related occupation in quality assurance.

Must possess three years of experience with a Masters and five years with Bachelors in:

Leading initial Quality Assurance on- the-floor assessments pertaining to real-time day- to- day manufacturing events including process excursions equipment alarms and operator errors to ensure timely execution of impact and risk assessments that preserve batch integrity and product quality .

cGMP regulations for the production of drug biologics or vaccine products.

Quality assurance in pharmaceutical or other regulated industry experience.

Deviation investigations and CAPA (Corrective Action/ Preventive Action).

Performing real-time review and approval of production batch records.

Systems such as DeltaV SAP Veeva TrackWise and MasterControl platforms.

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EEO Information

Fujifilm is committedto 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 ( or ).

Required Experience:

Senior IC