QA, Senior Specialist
QA, Sr. Specialist
Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.
Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
- Support Computer System Validation (CSV) projects.
- Assist with maintaining validated stated for all our current validated/qualified systems.
- Continues improvement of computer system validation program to include annual reviews and updates to IQ/OQ/URS/ SOPs, etc.
- Prepare audit schedule and assist with external audits as applicable.
- Track GXP vendor qualification/audits, ensuring timely completion of deliverables.
- Participate in writing, reviewing, and approving controlled documents, as needed.
- Track QA metrics (CAPAs, Deviations, Change Controls, Controlled Documents, Audits, etc.).
- Coordinate and track closure of internal Change Controls, Deviations, and CAPAs.
- Assist with other projects as needed.
Qualifications and Expertise
- Bachelor’s degree.
- A minimum of 3 year industry experience in Quality Assurance.
- Experience working in a GXP setting is required.
- Excellent communication skills, both oral and written.
- Excellent interpersonal skills, collaborative approach essential.
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Self-motivated with attention to detail and a strong sense of ownership in areas of responsibility.
- Working knowledge of Microsoft Word, Excel, and Adobe Acrobat Pro.
- Experience with Box, DocuSign, and ComplianceWire a plus.
- Experience with Veeva Vault QualitySuite (QualityDocs and QMS).
- Experience with Computer System Validation.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership.
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.