Biosciences QA & Compliance Specialist

W. L. Gore & Associates, Inc.; Flagstaff (AZ); On-site; USD 75,000 - 105,000; Full time

Job summary

W. L. Gore & Associates, Inc. seeks a Biosciences Quality Assurance professional to join the Biosciences Operations Team Quality Assurance Unit at its Flagstaff, AZ facility. You will help develop and maintain quality procedures and ensure regulatory compliance for nonclinical research.

You will conduct audits, provide training, support external inspections, and drive continuous improvement of quality systems to enable high-quality, compliant scientific work across bioscience operations.

Qualifications

• Bachelor's degree in life sciences, quality, engineering, regulatory affairs, or related field; 2+ years in quality systems, regulated research, audits, or compliance; or 6+ years in a regulated industry.
• Knowledge of GLP requirements or applicable quality system regulations.
• Ability to author, revise, and maintain controlled procedures and records.
• Ability to train, coach, or facilitate learning on quality system topics.
• Ability to interpret regulatory requirements and implement risk-based solutions.

Responsibilities

• Implement and improve quality systems, procedures, and programs for Biosciences research and operations.
• Conduct internal audits and assessments to ensure regulatory and quality compliance.
• Support external audits, inspections, accreditation reviews, and regulatory assessments.
• Deliver training and oversee Biosciences training programs and records.
• Collaborate with leaders to identify training needs and process improvements.
• Provide guidance on regulatory requirements, CAPA, investigations, and risk assessments.
• Administer IACUC and compliance activities, including protocol oversight.
• Manage document control, change control, event management, and eQMS processes.
• Develop quality metrics and reports to support compliance and performance.
• Collaborate cross-functionally to drive continuous improvement and risk reduction.

Skills

Quality systems

Audits

Training

Regulatory compliance

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Tools

eQMS

Document control software

Change control software

Job description

W. L. Gore & Associates, Inc. seeks a Biosciences Quality Assurance professional to join the Biosciences Operations Team Quality Assurance Unit at its Flagstaff, AZ facility. You will help develop and maintain quality procedures and ensure regulatory compliance for nonclinical research.

You will conduct audits, provide training, support external inspections, and drive continuous improvement of quality systems to enable high-quality, compliant scientific work across bioscience operations.