Quality Assurance-Compliance Specialist II-Audit and Inspection

Fujifilm • College Station, TX

280d

About The Position

The Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. The work we do at FUJIFILM Diosynth Biotechnologies 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 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 FUJIFILM Diosynth Biotechnologies call Genki.

Requirements

• High school diploma or GED and six (6) years of experience in a regulated industry, including two (2) years of experience of cGMP supporting pharmaceutical or biotechnology products.
• OR Associate degree in a related science concentration with 4 years of experience in a regulated industry, including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products.
• OR Bachelor's degree in a related science concentration with 2 years of experience of cGMP supporting pharmaceutical or biotechnology products.
• OR Master's degree in a related science concentration with 1 year of experience of cGMP supporting pharmaceutical or biotechnology products.

Nice To Haves

• Certified Quality Auditor
• Degree in Biology, Chemistry or Engineering

Responsibilities

• Work collaboratively with site management to instill a ‘Quality Culture' by coaching in the application of GMP Principles.
• Mentor peers towards achieving organizational and individual goals.
• Provide QA support during client audits and regulatory inspections.
• Display critical thinking expertise to define and implement a strategic approach to audits.
• Support client due diligence and Quality audits as well as regulatory inspections.
• Ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
• Ensure self-have no overdue training or site actions.
• Support other QA teams and functions in completion of site actions.
• Provide cGMP guidance to other functions such as Manufacturing, Facilities, QC, Warehouse, and Validations.
• Support Site Readiness Preparation for Regulatory Inspections.
• Stay aware and up to date with agency regulations and industry best practices.
• Execute audit strategy and lead process audits.
• Monitor quality in support of maintaining inspection readiness.
• Provide support during regulatory inspections or customer audits.
• Notify Senior Management of potential quality or regulatory issues.
• Ensure audit and inspection reports are responded to on time.
• Work on complex problems requiring in-depth evaluation of various factors.
• Interpret GMP regulations in the resolution of problems and in the design of systems.
• Plan, organize, and execute work to ensure deliverables are consistently met.
• Perform all other duties as assigned.

What This Job Offers

• Industry: Machinery Manufacturing
• Education Level: High school or GED