Systems Compliance Quality Specialist
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. According to Sera’s CEO, employees here must possess three qualities to be successful: 1) the individual must be passionate and dedicated to changing the world; 2) they must be smart and work smart; and 3) they must have absolute integrity. If this is you, we urge you to keep reading!
We are seeking a Systems Compliance Quality Specialist for our growing company.
- Maintains and enhances effectiveness of the Quality Management System by monitoring and managing the eQMS software.
- Develops and implements 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.
- Manages project teams to ensure proper design, validation, training, and communication occur during implementation of new modules and changes to existing.
- Accountable for the compliance of system by partnering with IT and the software vendor to ensure system security, backup, maintenance and upgrades as required.
- Writes, edits, and reviews procedures, work instructions, and validation documents associated with the eQMS.
- Collaborates to develop and provide training and technical assistance to new hires and ad-hoc as needed.
- Develops and reports metrics to management for actions needed to ensure compliance.
- Maintains data integrity and ensures compliance with company SOP’s, specifications; as well as CAP/CLIA, HIPAA, cGXP, ICH, FDA, and other local, state and federal regulations or guidelines.
- Ensures proper paper and electronic record retention related to the eQMS.
- 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 Quality commitment
- Strong written and oral communication with employees at all levels of the company
A successful 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
benefits for full-time employees:
The salary range for this role is between $80,000 and $90,000/yr and includes an excellent benefits package featuring an 85% to 95% premium paid healthcare plan, 13 paid holidays, three weeks of paid time off, employee stock options, and more!
Sera Prognostics requires attestation of COVID-19 vaccination at time of offer.