Sera is seeking an experienced Systems Compliance Quality Specialist to join our dedicated and growing team. As the Systems Compliance Quality Specialist, you will:
Maintain and enhance effectiveness of the electronic Quality Management System by monitoring and managing the eQMS software.
Develop and implement quality improvement initiatives utilizing eQMS modules to ensure that the system is utilized to its full capabilities and is maintained in compliance with regulatory requirements.
Manage project teams to ensure proper design, validation, training, and communication occur during implementation of new modules and changes to existing.
Are accountable for the compliance of systems by partnering with IT and the software vendor to ensure system security, backup, maintenance and upgrades as required.
Write, edit, and review procedures, work instructions, and validation documents associated with the eQMS.
Collaborate to develop and provide training and technical assistance to new hires and ad-hoc as needed.
Develop and report metrics to management for actions needed to ensure compliance.
Maintain data integrity and ensure compliance with company SOP’s, specifications; as well as CAP/CLIA, HIPAA, cGXP (current good manufcauting practices), ICH (international committee of harmonization), FDA, and other local, state and federal regulations or guidelines.
Ensure proper paper and electronic record retention related to the eQMS.
Perform other duties as assigned.
Associate degree in technical discipline (e.g. IT, biology, biotechnology, engineering) or related life science.
2-5 years of relevant professional experience.
Strong knowledge in Computer System Design and Life Cycle.
Excellent project management skills.
Strong attention to detail and commitment to quality.
Strong written and oral communication with employees at all level of the company.
A particularly strong candidate will also possess the following:
Bachelor's degree in technical discipline (e.g. IT, biology, biotechnology, engineering) or related life science.
Experienced in working to CAP/CLIA/GXP and Quality Management principles.
Experience with electronic Quality Management System software.
Experience working in a high-volume laboratory setting.
IT infrastructure and coding experience.
Telecommuting is allowed.
Additional Salary Information: The starting salary range for this position is between $80,000 - $90,000/yr. depending on experience and includes an excellent benefits package for full-time employees. Sera’s benefits package features an 85% to 95% premium paid healthcare plan, 13 paid holidays, three weeks of paid time off, employee stock options, and more!
About Sera Prognostics
Located on the edge of the beautiful Wasatch Mountains, Sera Prognostics, Inc. is a women’s health diagnostics company dedicated to improving the health of babies and mothers. We are a growing company tasked with becoming a global leader in high value women’s health diagnostics, delivering pivotal information to physicians that will improve health and improve the economics of healthcare delivery.