Quality Assurance Specialist - Hybrid in Bar Harbor ME

As a Quality Assurance Specialist you will be responsible for conducting thorough quality audits with internal teams and external suppliers to ensure compliance with company standards, industry regulations, and client expectations. In this role you will be involved in developing quality assurance policies, conducting tests and inspections, identifying and resolving production issues, and collaborating with teams to enhance product reliability. You will need to have a strong attention to detail, excellent analytical skills, and a solid understanding of quality assurance methodologies and regulatory standards.

Key Responsibilities (What you contribute)

• Develop and implement audit plans, conduct internal and supplier audits to ensure compliance with quality standards and supplier documentation.

• Evaluate quality control processes, ensure adherence to policies and standards, and review supplier documentation.

• Assist management during customer audits by preparing necessary documentation, facilitating audit tours and addressing customer inquiries.

• Support audit readiness by ensuring all processes and documentation meet and exceed customer expectations.

• Support customer audits in entirety, including but not limited to presenting to clients as needed; may act as an SME for operational questions and queries, and provides required supporting documentation in accordance with JAX policies.

• Prepare and communicate detailed audit reports outlining findings, corrective actions, and recommendations to enhance quality processes.

• Collaborate with internal teams and suppliers to develop and implement corrective actions for identified non-conformances while participating in continuous improvement initiatives to streamline processes, reduce errors, and enhance overall quality performance.

• Monitor the effectiveness of corrective actions, ensuring issues are resolved in a timely and satisfactory manner

• Track and analyze quality metrics to monitor trends, identify recurring issues, and assess supplier performance, while presenting regular updates to management and participating in continuous improvement initiatives to streamline processes, reduce errors, and enhance overall quality performance.

• Travel of up to 10% to JAX campuses and other supplier sites to conduct auditing.

Knowledge, Skills, and Abilities (What you're good at)

• An undergraduate degree or its international equivalent in STEM, health sciences, pharmacy, laboratory, clinical research, auditing, or a related field from an accredited institution.

• 3-5 years of experience in quality assurance, quality control, or auditing, ideally within the biomedical, pharmaceutical, or healthcare industry.

• Strong written and verbal communication skills.

• Excellent analytical and problem-solving skills with a keen attention to detail.

• Highly organized with a logical, systematic, and curious approach; capable of gathering, analyzing, and interpreting relevant information to make improvement recommendations.

• Ability to thrive in a high-volume, strict-deadline environment.

• Proven ability to manage multiple projects and deadlines.

• Experience in presenting conclusions clearly and concisely.

• Demonstrated ability to identify deviations from quality standards during audits and propose appropriate corrective actions.

• Capable of conducting work with minimal supervision or guidance from QA management or more experienced auditors.

• Ability to travel domestically for supplier or internal audits as needed, up to 10% of the time.

Education: Bachelor's required/ Bachelor's preferred

Experience: 3 years required/ 5 years preferred

Supervisory: None

Pay Range: $69,711 - $101,081

About JAX:

The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California), Japan and China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.

Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease. It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community. For more information, please visit www.jax.org.

EEO Statement:

The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non-discrimination laws.