QA Specialist / Sr. QA Specialist
IGM Biosciences, Inc. (NASDAQ: IGMS) is a clinical stage biotechnology company focused on creating and developing engineered IgM antibodies. IgM antibodies have inherent properties that we believe may enable them to improve upon the efficacy and safety of IgG antibodies in multiple therapeutic applications.
We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists and targeted cytokines. Our lead product candidate, IGM-2323, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3, that is currently in a Phase 1 clinical trial for the treatment of relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL). Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with solid and hematologic malignancies. Also in our product pipeline is IGM-7354, a bispecific IgM antibody delivering interleukin-15 (IL-15) cytokines to PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies.
In this new role at IGM, you will perform quality assurance activities related to clinical and commercial supplies for on-site and external manufacturing. The QA Specialist will report to the Supervisor of Quality.
- Issue, route, and approve document change control records. File completed DCRs in approved paper and electronic locations.
- File all approved GxP documents and document revisions in approved paper and electronic storage.
- Generate, review and/or format all new/revised GxP documentation for compliance with document management SOP(s).
- Ensure that document periodic review is conducted as required.
- Issue and review approved Batch records for production activities.
- Issue training notifications for all new and revised GxP documents.
- Track training completion and issue reminder notifications.
- File completed training records in personnel training files.
- Maintain internal Quality Systems in support of GMP manufacturing.
- Participate and track change control, deviations, CAPA, batch release review, validation review, raw material inspection, and risk managements.
- Support audits/inspections as assigned.
- Support maintenance of supplier quality by tracking qualifications/qualifications and schedule audits.
- Periodically review logbooks in the GMP facility for good documentation and compliance
- Behave as QA on the floor during production for line clearance and/or change overs.
- BA or BS degree in a scientific discipline required, or comparable experience.
- Must have excellent verbal, written, interpersonal, organizational and communication skills.
- Great organizational ability to manage a wide range of tasks.
- Attention to detail and accuracy.
- Adaptability and a high degree of flexibility.
- The ability to work independently and as part of a team.
- Familiarity with ZenQMS preferred.
- Competence in administrative procedures and project management ability.
- Strong background in Good Documentation Practices.
- Previous experience in GMP environment desirable.
- Must be able to commute to Mountain View
- Medical, dental and vision insurance. The full premium amount for our employees and their dependents is covered by IGM
- STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
- 401(k) Plan
- 120 hours of Paid Time Off, 5 sick days per year, 10 holidays
- Cell phone & internet subsidy
- Employee Referral Bonus Program
- Annual training budget for professional development
- Commuter Benefit
- Annual bonus program
- New hire stock options
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.