Biosciences Quality Assurance

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

We are looking for a Biosciences Quality Assurance professional to join our team. In this role, you will be part of the Biosciences Operations Team Quality Assurance Unit, which is responsible for the development, management, and continuous improvement of quality procedures and systems that ensure compliance with applicable regulations and standards supporting research conducted by the Biosciences Team. You will partner with research, veterinary, technical, and operational teams to maintain inspection readiness, assess compliance, strengthen quality system processes, and translate regulatory expectations into practical, risk-based solutions. Through audits, assessments, quality guidance, metrics, and cross-functional collaboration, you will help reduce risk, improve operational performance, and enable high-quality, compliant scientific work. This highly collaborative role offers broad exposure to regulated nonclinical research and the opportunity to make a meaningful impact on the effectiveness and continued advancement of Biosciences operations.

This role will be located at our facility in Flagstaff, Arizona.

Responsibilities

• Implement, maintain, and continuously improve quality systems, procedures, and programs supporting Biosciences research, animal care, and operational activities
• Conduct internal audits and assessments to ensure compliance with applicable regulations, quality standards, animal welfare requirements, and organizational policies
• Support the planning, hosting, and response activities associated with external audits, inspections, accreditation reviews, and regulatory assessments
• Deliver training, coaching, and oversight of the Biosciences training program, including curricula, qualification requirements, training records, and effectiveness monitoring
• Partner with functional leaders and subject matter experts to identify training needs and support implementation of new or revised processes and procedures
• Provide guidance on regulatory requirements, quality system expectations, investigations, nonconformances, CAPA, risk assessments, and related compliance activities
• Administer and support the Institutional Animal Care and Use Committee (IACUC) and compliance activities, including program reviews, protocol oversight processes, corrective actions, and implementation of animal care and use requirements
• Administer and support quality system processes including document control, change control, event management, training, CAPA, root cause analysis, risk assessments, continuous improvement efforts, and electronic quality management systems
• Develop and communicate quality metrics, trends, reports, and recommendations to support compliance, animal welfare, training effectiveness, and operational performance
• Collaborate with cross-functional teams to drive continuous improvement, risk reduction, and practical, science-based solutions that support compliant and efficient Biosciences operations

Required Qualifications

• Bachelor’s degree in life sciences, quality, engineering, regulatory affairs, or a related field with a minimum of 2 years of experience in quality systems, regulated research, laboratory operations, audits, inspections, or compliance reviews; or a minimum of 6 years of directly relevant experience supporting the processes and responsibilities outlined above in the medical device industry or another relevant regulated industry may be considered
• Working knowledge of Good Laboratory Practice (GLP) requirements and applicable quality system regulations, standards, or guidance documents
• Demonstrated ability to author, revise, review, and/or maintain controlled procedures, records, and quality system documentation
• Demonstrated ability to train, coach, or facilitate learning on quality system requirements, regulatory expectations, and operational procedures
• Ability to interpret regulatory and quality requirements, assess compliance risks, and implement practical, risk-based solutions in collaboration with process owners
• Strong verbal, written, and presentation skills with the ability to communicate effectively with technical staff, study personnel, leadership, inspectors, internal and stakeholders
• Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic operational environment
• Ability to work effectively across functions, influence outcomes and build collaborative relationships with diverse stakeholders
• Ability to support of Biosciences operations and travel up to 5% as needed

Desired Qualifications

• Minimum of 2 years of experience supporting nonclinical, animal research, veterinary, laboratory, or regulated scientific operations, including direct support of studies under 21 CFR Part 58 and familiarity with applicable DEA, USDA, Animal Welfare Act, IACUC, or related requirements
• Minimum of 2 years of direct experience supporting regulatory inspections and/or independently planning, conducting, documenting, and following up on internal or supplier audits
• Minimum of 2 years of hands-on experience administering electronic quality management systems, including document control and change management workflows

For over 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. Our Associates build on a rich history of innovation, upholding Gore’s values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

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