Senior QA Analyst

HireLifeScience; College Station (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies Texas LLC in College Station, TX is seeking a Senior QA Analyst to review and approve critical documentation, participate in quality audits, and support QA compliance across drug, biologics or vaccine production.

Candidate must have advanced degree with relevant QA experience; familiarity with cGMP, CAPA, and batch record reviews is required. Strong cross-functional coordination and vendor/client QA collaboration are essential.

Qualifications

• Master’s or Bachelor’s degree as specified with required years of QA experience.
• Experience performing quality assurance activities in regulated environments.
• Knowledge of cGMP for drug/biologic/vaccine production.
• Experience with deviation investigations and CAPA.
• Experience reviewing production batch records and technical documents.

Responsibilities

• Review and approve basic and technical documentation with minimal supervision.
• Lead QA audits and participate in vendor, supplier, and client audits.
• Provide guidance to manufacturing, QC, and other departments on QA requirements.
• Support regulatory, client, and internal audits and ensure compliance with standards.
• Act as QA liaison to internal teams and external client groups.

Skills

QA auditing

Regulatory compliance

CAPA

Documentation review

Cross-functional collaboration

Education

Master's degree in Project Management/Biology/Chemistry or related field

Bachelor's degree in Project Management/Biology/Chemistry or related field

Tools

DeltaV

SAP

Veeva

TrackWise

MasterControl

Job description

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 important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's 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 you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what 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, it's a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Requirements:

Master's 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 Bachelor's 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 Master's and five years with Bachelor's 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.

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 ([e-mail] or [phone]).