About SeromYx
SeromYx Systems is a biotechnology service company that provides clients and partners with unprecedented insight into the functional antibody response, based on the Systems Serology platform developed at the Ragon Institute of MGH, MIT and Harvard. Systems Serology is increasingly recognized as the gold standard in interpreting humoral immune responses and correlating them with clinical outcome. As such, it is being used to tackle many of the most pressing and important challenges in immunology: see, for example, its use to develop a malaria vaccine, Suscovich et al., Sci. Transl. Med. 12, eabb4757 (2020) 22 July 2020. Malaria is one of the largest causes of mortality in children under 5 globally.
Starting operations at the end of 2019, in its first two and a half years, SeromYx has doubled in size, driven by client demand in both vaccines and monoclonal therapeutics, and targets ranging from blockbuster indications to neglected tropical diseases. SeromYx has made significant contributions to the fight against SARS-COV-2, including support for Phase 3 trials, natural history of disease longitudinal studies, multinational correlates of protection/vaccine breakthrough analyses, next generation vaccine development support and the characterization of several therapeutics including monoclonal antibodies. Clients range from the world’s largest pharmaceutical and vaccine companies to biotechs to leading non-governmental public health organizations.
Looking forward, we expect a further growth of 50-100% in revenues and profits, as we support the discovery and development of second-generation coronavirus vaccines, as other client projects move into BLA-enabling studies, as we expand our NTD business and as we grow into new therapeutic areas such as autoimmunity and oncology. As one further consequence of our success, we outgrew our original space and moved into new build custom labs in Woburn, MA. in Q2 2022.
SeromYx has now reached the stage in its growth where it needs a dedicated Quality Assurance professional focusing on building and maintaining our quality management systems.
Job description
SeromYx is seeking a talented, experienced, and motivated individual to join our growing team as a QA Specialist. The successful candidate has experience in performing QA functions in a pharmaceutical or pharmaceutical services environment. Experience in a GxP or CAP/CLIA environment is required.
As the first dedicated in-house QA professional, the successful candidate will lead the creation of a high compliance environment and spearhead continuous improvement in the quality department.
The position reports to the Director, Operations.
Key Responsibilities
- Manage the Quality Management System (QMS) program (i.e. Document Control, Deviations, CAPAs, Vendor Management, Archiving, External Audits, and Internal Audits)
- Support the implementation of continuous improvement of QMS
- Monitor the performance of the QMS, including creation of key performance indicators (KPI) and reviewing KPI with management
- Perform internal audits of the quality system quarterly
- Perform and maintain external vendor assessments, as needed
- Review ongoing or completed studies to ensure compliance with study plans, contracts, and approved SOPs
- Act as a contact with vendors or regulatory authorities. Participate in customer, vendor, and regulatory audits
- Review equipment maintenance, certification, and calibration documents
- Provide support for validation and qualification of equipment and computer systems
Qualifications
- B.A. or B.S. in a life science discipline (technology, biological science, pharmacy, or other health related discipline preferred)
- 3 to 5 years’ experience in quality related functions
- Strong written and verbal communications skills
- A self-starter, comfortable in a small company, dynamic, environment
- Experience in building and maintaining quality systems
- Working knowledge of 21CFR Part 11 and computerized systems regulations
More information on SeromYx and our technology is available at our website, www.seromyx.com.
What we offer
Beyond competitive salary and full benefits, including generous paid vacation and 401K with match, at this stage of its development, SeromYx offers unparalleled opportunities for professional growth and undiluted equity participation via a stock option program.
SeromYx embraces diversity and is committed to equal employment opportunity for all its employees and qualified applicants. No employee or applicant for employment will be discriminated against in recruitment, hiring, training, promotion, or any other employment practices on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. At this time, SeromYx will not be able to sponsor any visas.
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