Biosciences Quality Assurance Specialist

Sitka Inc.; Flagstaff (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Gore is seeking a Biosciences Quality Assurance professional to join the Operations Team Quality Assurance Unit in Flagstaff, AZ. You will develop, manage, and improve quality systems ensuring compliance with regulations and standards supporting regulated bioscience research.

You will partner across research, veterinary, technical, and operational teams to maintain inspection readiness, translate regulatory expectations into practical solutions, and lead internal audits, CAPA, risk assessments,

Qualifications

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

Responsibilities

• Implement, maintain, and improve quality systems, procedures, and programs for Biosciences research and operations.
• Conduct internal audits and assessments to ensure compliance with regulations and animal welfare requirements.
• Support external audits, inspections, accreditation reviews, and regulatory assessments.
• Deliver training and oversight of the Biosciences training program, including curricula and records.
• Identify training needs with stakeholders and support new or revised processes.
• Provide guidance on regulatory requirements, CAPA, investigations, and risk assessments.
• Administer IACUC and compliance activities, including protocol oversight and corrective actions.
• Administer quality system processes including document/change control, event management, and corrective actions.
• Develop quality metrics and communicate trends and recommendations for compliance and performance.
• Collaborate across functions to drive continuous improvement and risk reduction.

Skills

GLP knowledge

Quality systems

Audits

Regulatory communications

Training & coaching

Education

Bachelor’s degree in life sciences

6+ years in regulated industry

Tools

Electronic Quality Management System

Job description

Gore is seeking a Biosciences Quality Assurance professional to join the Operations Team Quality Assurance Unit in Flagstaff, AZ. You will develop, manage, and improve quality systems ensuring compliance with regulations and standards supporting regulated bioscience research.

You will partner across research, veterinary, technical, and operational teams to maintain inspection readiness, translate regulatory expectations into practical solutions, and lead internal audits, CAPA, risk assessments,