Quality Assurance Analyst, Sr. - Healthcare jobs in Bangor, ME

The Quality Assurance Analyst will play a pivotal role in enhancing and maintaining The Jackson Laboratory's electronic Quality Management System (eQMS). We are seeking a candidate who is highly process-driven, excels in organization, and exhibits meticulous attention to detail.

The salary range is $78,595 - $122,730. Salary will be determined based on qualifications and experience.

The candidate hired into this position will work onsite to perform audits (efficiency checks) at either the Sacramento, CA or Bar Harbor, ME locations.

Key Responsibilities and Essential Functions

• Lead and Manage Critical eQMS Processes
• Oversee important Quality Management System processes, including but not limited to, Corrective and Preventive Action (CAPA) & Deviations
• Conduct root-cause analyses based on returned information or identified issues for Supplier Management, Change Management, and Document Control.
• eQMS Support and Compliance: Assist staff in effective management and adherence to compliance standards for various eQMS elements.
• Contribute to the enhancement of the overall eQMS, responsibilities including:
• Maintenance and administration of eQMS components.
• Creation, review, verification, and approval of system documentation.
• Assist in the development and implementation of eQMS-related training programs and materials.
• Generate and analyze metrics about assigned Quality Management element(s).
• Monitor process and system performance continuously.
• Lead initiatives aimed at enhancing quality and process efficiencies.
• Engage in ongoing improvement efforts based on user feedback, process evaluation, and performance results.
• Serve as an integral member of teams focused on proactive Quality projects
• Undertake other projects and duties as required, demonstrating flexibility and adaptability.

Knowledge, Skills, and Abilities

• Bachelor's Degree (Master's Degree Preferred)
• Two or more years of relevant experience. Relevant experience includes: Running CAPAs/evaluating deviations, leading root cause analysis discussions, using industry tools (fishbone diagram, 5 whys), auditing experience and or other quality management experience.
• Strong experience using Microsoft Excel
• Lean or Six Sigma Certification (Preferred)
• EtQ Reliance Certification (Preferred)
• The incumbent must have experience with the management of an eQMS and all that this entails including software maintenance, development and implementation of training and materials, metric tracking etc.
• The incumbent shall also have experience with quality practices including root cause analysis, other data analysis, CAPA management, and process improvement.
• Experience with Lean Six Sigma ideologies is also preferred.

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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 andChina. 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.

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.