Quality Assurance Specialist / Sr. QA Specialist
IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer, infectious diseases, and autoimmune and inflammatory diseases. IgM antibodies have inherent properties that we believe may enable them to bind more strongly to targets on the surface of cells than comparable IgG antibodies. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers.
Our lead product candidate, Imvotamab, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins, and it is currently in two Phase 2 clinical trials for the treatment of relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with relapsed and/or refractory solid and hematologic malignancies, and it is currently in a Phase 1 clinical trial. Also in our product pipeline is IGM-7354 and IGM-2644. IGM-7354 is an anti-PD-L1 IgM antibody that targets the delivery of interleukin-15 (IL-15) cytokines to the area of PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies. IGM-2644 is a bispecific T cell engaging IgM antibody targeting CD38 and CD3 proteins for the treatment of patients with multiple myeloma.
Position Summary
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 Manager of Quality.
Responsibilities:
- 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.
Qualifications:
- 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.
Comprehensive Benefits:
- Medical, dental and vision insurance.
- The full premium amount for our employees and their dependents is covered by IGM
- FSA (Flexible Spending Account)
- 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, 11 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.