Quality Assurance-Compliance Specialist III-Audit and Inspection

Fujifilm • College Station, TX

280d

About The Position

The Quality Assurance - Compliance Specialist III - 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 or equivalent: 8 years or more experience in Pharmaceutical or other regulated Industry.
• Associates Degree: 5 years or more experience in Pharmaceutical or other regulated Industry.
• Bachelor's degree: 3 years or more experience in Pharmaceutical or other regulated Industry.
• Master's Degree: 2 years or more experience in Pharmaceutical or other regulated Industry working in Audit and Inspection.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to set personal performance goals and provide input to departmental objectives.
• Ability to multitask and easily prioritize work.

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.
• Ensure 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 updated with agency regulations, guidance documents, 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 met.
• Support client due diligence and Quality audits.

Benefits

• Equal opportunity and affirmative action employer.
• Reasonable accommodations for individuals with disabilities.

What This Job Offers

• Career Level: Mid Level
• Industry: Machinery Manufacturing