QA Specialist III, QA Validation

FUJIFILM Biotechnologies; College Station (TX); On-site; USD 86,000 - 160,000; Full time

Job summary

Join FUJIFILM Biotechnologies as a QA Specialist III, leading crucial validation processes in a vibrant team focused on quality assurance and regulatory compliance. Ideal candidates will hold advanced degrees and possess significant experience in the regulated industry, ensuring adherence to quality standards and driving business growth. This role offers an opportunity to help advance medicine through dedication and expertise in QA.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

Qualifications

• Experience in qualification and computer validation.
• Knowledge of cGMP regulations for pharmaceuticals.
• Strong team collaboration and proactive leadership.

Responsibilities

• Lead the review and approval processes for validation protocols.
• Ensure compliance with local/global quality standards.
• Engage in new business growth through audits and inspections.

Skills

Organizational skills

Analytical skills

Report writing skills

Proficiency in Microsoft Excel

Proficiency in Microsoft Word

Proficiency in Microsoft PowerPoint

Education

Master's degree with 2+ years or Bachelor's degree with 3+ years in a regulated industry

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

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Direct message the job poster from FUJIFILM Biotechnologies

Senior Recruiter for FUJIFILM Diosynth Biotechnologies (through NXTThing RPO)

We're hiring for a QA Specialist III, QA Validation at FUJIFILM Biotechnologies in College Station, TX! Join a dedicated team committed to excellence in Quality Assurance, ensuring compliance and advancing medicine for a better tomorrow. #QACareers #BiotechJobs

Are you ready to make your mark in the world of pharmaceutical validation? As a QA Specialist III, you will lead the review and approval processes for validation protocols, collaborate across teams to instill a strong 'Quality Culture', and ensure adherence to industry standards. Your expertise will be pivotal in maintaining our regulatory compliance.

• Ensure compliance with local/global quality standards and partner commitments
• Engage in new business growth through audits and inspections
• Review and approve master plans and validation protocols
• Lead investigations for discrepancies and corrective actions
• Master's with 2+ years, Bachelor's with 3+ years, or equivalent experience in a regulated industry
• Expertise in qualification and computer validation experience
• Strong organizational, analytical, and report writing skills
• Proficiency in Microsoft Excel, Word, and PowerPoint
• Knowledge of cGMP regulations for pharmaceuticals

About FUJIFILM Biotechnologies: We're at the forefront of innovation, developing life-changing medicines in a collaborative, vibrant environment in College Station, TX. Join us in fulfilling our Group Purpose: “giving our world more smiles.”

If you're a proactive leader with a passion for quality assurance, we want to hear from you! Apply now and be part of a team dedicated to transforming the future of medicine. #QAJobs #JoinUs

Visit us to apply: https://www.fujifilm.com/us/en/about/region/careers

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

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