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QA Analyst I - All Shifts

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Job LocationsUS-TX-College Station

Posted Date

3 hours ago

(12/11/2024 12:03 PM)

Requisition ID : 2024-32728

Category : Quality Assurance

Company (Portal Searching) : FUJIFILM Diosynth Biotechnologies

Overview

The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

The Quality Assurance (QA) Analyst I, under direct supervision, will be

responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements.

Reports to

Supervisor/Manager, QA

Work Location

College Station, TX

Primary Responsibilities:

• Assist with review of basic documentation to include, but not limited to:
• Standard Operating Procedures
• Corrective Action/Preventive Action Plans
• Data Reports
• Assist with review of internal quality policies, procedures, and reports.
• Assist with inspection of final product containers and review and/or approval of executed process records and data.
• Assist in Quality audits to include, but not limited to:
• Audit of lab notebooks
• Audit of equipment logbooks
• Review of vendor, supplier, contract laboratory audit questionnaires
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as needed.

Qualifications:

Bachelors degree in a related science concentration with some experience in pharmaceutical or other regulated industry; OR

Associates degree in a related science concentration with 2+ years of experience in pharmaceutical or other regulated industry; OR

High School Diploma or GED with 4+ years of experience in pharmaceutical or other regulated industry required.

ASQ Certification preferred.

Knowledge of GM