QA Specialist - Drug Product

Overview

The work we do at FDB has never been more important—and 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 people’s lives. Join FDB and help manufacture 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 we call Genki.

We are looking for a QA Specialist, who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. 

During the project phase, the QA Specialist will partner in the Quality oversight of Drug Product manufacturing processes (formulation/fill/inspection) through to operational readiness, as well as provide oversight of validation program execution for these processes. You will collaborate within the DP Quality team as well as with other project teams, and with QA departments at other sites to align strategies and procedures.

Once in operations, you will continue to ensure that applicable DP systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. Additionally, you may participate in optimization or improvement initiatives and support regulatory agency and third-party inspections.

External US

Basic Requirements

• BS/BA or equivalent and 3 years of applicable experience.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility, is required. 
• Excellent oral and written communications skills and fluency in English

Preferred Requirements

• 1 years experience in a Quality role is preferred.
• Working knowledge of ASTM E2500, Smartsheet and/or Kneat validation software is a plus
• Familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies is a plus
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 is a plus
• Understanding of one or more of the following processes preferred:
• formulation
• aseptic filling
• visual inspection
• finished goods manufacturing
• Occasional opportunity for International and/or Domestic travel may be available
• Training and/or familiarity with Quality Risk Management principles is a plus