Biosciences Quality Assurance Specialist

W. L. Gore & Associates; Flagstaff (AZ); Presencial; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

W. L. Gore & Associates in Flagstaff, AZ seeks a Biosciences Quality Assurance professional to lead quality systems and regulatory compliance within the Biosciences Operations Team.

You will drive audits, training, CAPA, and risk-based improvements to ensure inspection readiness and high-quality scientific work. You will partner with researchers, veterinary staff, and operations to translate regulatory expectations into practical processes, supporting continuous improvement and animal welfare

Formación

• 2+ years in quality systems, regulated research, laboratory operations, audits, inspections, or compliance reviews; or 6+ years in a regulated industry may be considered.
• Working knowledge of GLP requirements and applicable QSRs/standards or guidance documents.
• Ability to author, revise, review, and maintain controlled procedures and quality system documentation.
• Ability to train, coach, or facilitate learning on quality system requirements and regulatory expectations.
• Interpret regulatory and quality requirements and implement risk-based solutions with process owners.
• Strong communication skills with technical staff, leadership, and inspectors.
• Excellent organization, analysis, and problem-solving skills; manage multiple priorities.

Responsabilidades

• Implement and continuously improve quality systems, procedures, and programs supporting Biosciences research and operations.
• Conduct internal audits and assessments to ensure compliance with regulations, standards, and animal welfare requirements.
• Support external audits, inspections, accreditation reviews, and regulatory assessments.
• Deliver training and oversight of the Biosciences training program, including curricula, qualifications, and training records.
• Identify training needs with functional leaders and implement new or revised processes.
• Provide guidance on regulatory requirements, quality system expectations, investigations, CAPA, risk assessments.
• Administer IACUC and compliance activities, including program reviews and protocol oversight.
• Administer and support quality system processes including document control, change control, event management, CAPA, root cause analysis, risk assessments, continuous improvement, and electronic QMS.
• Develop and communicate quality metrics, trends, reports, and recommendations to support compliance and operational performance.
• Collaborate with cross-functional teams to drive continuous improvement and practical, science-based solutions.

Educación

Bachelor's degree in life sciences, quality, engineering, regulatory affairs, or a related field

Herramientas

GLP knowledge

Quality systems documentation

Audits and inspections

CAPA and risk assessment

IACUC familiarity

Descripción del empleo

W. L. Gore & Associates in Flagstaff, AZ seeks a Biosciences Quality Assurance professional to lead quality systems and regulatory compliance within the Biosciences Operations Team.

You will drive audits, training, CAPA, and risk-based improvements to ensure inspection readiness and high-quality scientific work. You will partner with researchers, veterinary staff, and operations to translate regulatory expectations into practical processes, supporting continuous improvement and animal welfare