Quality Assurance Specialist Quality Systems

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Quality, California

Expiry Date :
Sat, 17 Apr 2021 23:59:59 GMT

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Job Details Estimated: $66,000 – $86,000 a year2 hours ago Benefits – Health insurance Qualifications – Statistical analysis – Analysis skills – Quality assurance – Communication skills – Project management – Bachelor’s degree Full Job Description Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life. Our team is expanding rapidly and we’re looking for people who are passionate about helping improve healthcare to join us. Invitae is a rapidly growing, technology-driven genetics testing company. Our mission is to empower doctors and patients to use genetic & genomic information to make informed medical decisions at all life stages. We are seeking an experienced Quality Assurance Specialist who will support global quality activities to ensure compliance with the Invitae Quality Management System (QMS). You will provide leadership, implementation, and oversight of the electronic Quality Management System in an Invitae location. What you will do: Understand organizational and departmental strategy to draft, interpret, and implement quality assurance standards and procedures for a federated hybrid eQMS. Evaluate and ensure quality assurance protocols fulfill new and existing regulatory requirements. Ensure Quality System is clearly defined and consistently deployed throughout the organization. Ensure quality processes through regular auditing and testing. Create, monitor, analyze, and report on Quality System Key Performance Indicators (KPIs). Ensure indicators accurately represent system health. When indicated, investigate and initiate corrective actions and/or identify opportunities for improvements. Participate and lead in the continuous improvement initiatives intended to improve quality and reliability; effectiveness and efficiency of the processes. Collaborate with laboratory leaders to set up processes for ongoing audit readiness. Collaborate with, provide guidance, and support the Site QA teams to ensure appropriate coordination and integration of CAPAs, document control, record management, change control, training and competency processes. Seek and make recommendations to improve the Quality System. Support the users of eQMS. Who you are: 3 years experience in Quality Assurance with a bachelor’s degree or equivalent. Work experience in the biologics/biopharmaceutical/medical diagnostic industries, preferably in a laboratory setting. Working knowledge of CLIA, CAP, California, and NYS standards and regulations. GxP familiarity preferred. Strong cross-functional communication skills. Experience developing policies and procedures. Experience preparing for audits and hosting inspections from a regulatory agency. Demonstrated experience to lead change. Attention to detail and analytical skills required. Good organizational, project management, and prioritization skills. Demonstrated proficiency with developing processes utilizing collaboration tools and eQMS systems. Statistical analysis experience preferred. Ability to make decisions in ambiguous situations and requiring minimal supervision. By joining Invitae, you’ll work alongside some of the world’s experts in genetics and healthcare at the forefront of genetic medicine. We’ve created a culture that empowers our teams and our teammates to have the biggest impact and to explore their interests and capabilities. We prize freedom with accountability and offer significant flexibility, along with excellent benefits and competitive compensation in a fast-growing organization. Join us. At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance. Quick