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Quality Assurance Specialist I

2 months ago


College Station Texas, United States Fujifilm Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist I - Audit and Compliance to join our team at Fujifilm Diosynth Biotechnologies. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Support Audit Responsibilities: Collaborate with site management to ensure compliance with Fujifilm Diosynth Biotechnologies quality policies and site standard operating procedures (SOPs).
  • Regulatory Compliance: Support client audits, regulatory inspections, and conduct internal and supplier audits to ensure regulatory compliance.
Essential Functions
  • Leadership and Coaching: Work collaboratively with site management to instill a quality culture by coaching in the application of Good Manufacturing Practices (GMP) principles.
  • Compliance Delivery: Support the organization in conducting internal audits and hosting audits/inspections.
  • New Business Growth: Work with quality management to ensure quality systems support current Good Manufacturing Practices (cGMP) manufacturing of pre-clinical to commercial products.
  • Compliance: Support the external and internal audit programs to ensure compliance with regulatory requirements.
Responsibilities
  • Audit Preparations and Conduct: Responsible for audit preparations, conducting internal audits, and assisting client audits with site documentation gathering.
  • Global Supplier Assurance: Support the global team to participate and represent the Texas site in supporting joint audits.
  • Training and Support: Ensure no overdue training and support other QA teams and functions in completing site actions.
Requirements
  • Excellent Communication Skills: Possess excellent written and oral communication skills.
  • Organizational and Analytical Skills: Demonstrate excellent organizational, analytical, data review, and report writing skills.
  • Goal Setting and Prioritization: Ability to set personal performance goals and provide input to departmental objectives.
  • Multitasking and Prioritization: Ability to multitask and easily prioritize work.
Working Conditions and Physical Requirements
  • Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Reasonable Accommodations: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Prolonged Standing and Sitting: Experience prolonged standing, some bending, stooping, and stretching.
  • Computer Work: Ability to sit for long periods to work on a computer.
  • Exposure to Hazardous Materials: Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
Minimum Qualifications
  • Education and Experience: Bachelor's degree in a related science concentration with some experience in quality assurance supporting pharmaceutical or biotechnology products; OR Associate degree in a related science concentration with two (2) years of experience in quality assurance supporting pharmaceutical or biotechnology products; OR High School Diploma or GED with four (4) years of experience in quality assurance supporting pharmaceutical or biotechnology products.
Preferred Qualifications
  • GMP/GLP Knowledge: Knowledge of GMP/GLP regulations.
  • Related Degree: Degree in Biology, Chemistry, or Engineering.

Fujifilm Diosynth Biotechnologies is an equal opportunity and affirmative action employer. We are committed to diversity and inclusion in the workplace.