Quality Assurance-Compliance Specialist III-Audit and Inspection

FUJIFILM Diosynth Biotechnologies; College Station (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company is seeking a Quality Assurance-Compliance Specialist III to ensure compliance with quality policies and support audits and inspections. The role requires strong communication and analytical skills, with a focus on fostering a quality culture within the organization.

Benefits

Flexible work environment

Qualifications

• 8+ years in Pharma or regulated industry required.
• Experience in Audit and Inspection is essential.

Responsibilities

• Support QA during client audits and regulatory inspections.
• Develop strategic audit approaches based on compliance knowledge.
• Mentor peers and foster a 'Quality Culture'.

Skills

Communication

Organizational Skills

Analytical Skills

Report Writing

Multitasking

Education

High school diploma or equivalent

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Job description

Quality Assurance-Compliance Specialist III-Audit and Inspection

Join to apply for the Quality Assurance-Compliance Specialist III-Audit and Inspection role at FUJIFILM Diosynth Biotechnologies

Summary

The Quality Assurance - Compliance Specialist III - Audit and Inspection will support all responsibilities related to compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

Company Overview

At FUJIFILM Diosynth Biotechnologies Texas, our work is vital. We seek passionate, mission-driven individuals eager to make a difference in healthcare, from vaccine development to cell and gene therapies. We collaborate with industry leaders to address complex challenges and deliver impactful solutions.

Join us in transforming the future of medicine. We offer a flexible work environment and foster a culture we call Genki, which fuels passion, energy, and drive. Our state-of-the-art facility is located in College Station, Texas, offering a blend of small-town charm and vibrant culture, with proximity to major urban centers.

Fujifilm is headquartered in Tokyo, with over 70,000 employees across healthcare, electronics, business innovation, and imaging sectors. Our purpose is “giving our world more smiles.” More information at: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Essential Functions:

Leadership

• Collaborate with site management to foster a ‘Quality Culture’ by coaching on GMP principles and their rationale.
• Mentor peers to achieve organizational and individual goals.

Compliance

• Support QA during client audits and regulatory inspections to assess compliance and effectiveness.
• Apply critical thinking to develop strategic audit approaches based on compliance and business knowledge.
• Ensure timely completion of training and site actions; support other QA teams.
• Provide cGMP guidance to Manufacturing, Facilities, QC, Warehouse, and Validations.
• Assist in Site Readiness for Regulatory Inspections.
• Stay updated with agency regulations, guidance, and industry best practices.
• Lead audit strategies and process audits.
• Monitor quality to maintain inspection readiness.
• Support regulatory inspections and customer audits as needed.
• Notify Senior Management of potential quality or compliance issues.
• Respond promptly to audit and inspection reports.
• Handle complex problems requiring in-depth analysis and GMP regulation interpretation.
• Plan, organize, and execute work to meet deliverables.

New Business Growth

• Support client due diligence, quality audits, and regulatory inspections.
• Work with Quality management to support quality systems for cGMP manufacturing.
• Perform other duties as assigned.

Required Skills & Abilities

• Excellent communication skills, both written and oral.
• Strong organizational, analytical, and report-writing skills.
• Ability to set and meet personal and departmental goals.
• Multitasking and prioritization skills.

Qualifications

• High school diploma or equivalent with 8+ years in Pharma or regulated industry.
• Associate’s Degree with 5+ years of experience.
• Bachelor’s Degree with 3+ years of experience.
• Master’s Degree with 2+ years of experience in Audit and Inspection.

Preferred Qualifications

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

Working Conditions & Physical Requirements

Employees must meet physical demands, including prolonged standing, bending, and potential exposure to hazardous materials. Personal protective equipment is required, and occasional lifting up to 25 pounds. Flexibility to work off-hours, weekends, and travel is necessary. Attendance is mandatory.

For accommodations, contact [e-mail] or call 979-431-3500.

Equal Opportunity & ADA Statements

We are committed to equal opportunity employment and reasonable accommodations for applicants with disabilities.