::: {tabindex="-1"}

Senior QA Analyst - All Shifts

:::

Job LocationsUS-TX-College Station

Posted Date

7 days ago

(12/26/2024 7:02 PM)

Requisition ID : 2024-32915

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 Senior Quality Assurance (QA) Analyst, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of 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. They will also provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager.

Reports to

Director/Senior Manager/Supervisor, Quality Assurance

Work Location

College Station, TX

Primary Responsibilities:

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
• 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 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

[]{style="

"}