QA, Senior Specialist
Company: Allakos, Inc.
Location: Redwood City
Posted on: November 22, 2021
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. Your
- Support Computer System Validation (CSV) projects.
- Assist with maintaining validated stated for all our current
- 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
- 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
- Bachelor's degree.
- A minimum of 3 year industry experience in Quality
- Experience working in a GXP setting is required.
- Excellent communication skills, both oral and written.
- Excellent interpersonal skills, collaborative approach
- 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
- Experience with Box, DocuSign, and ComplianceWire a plus.
- Experience with Veeva Vault QualitySuite (QualityDocs and
- 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.
Keywords: Allakos, Inc., Redwood City , QA, Senior Specialist, Other , Redwood City, California
Didn't find what you're looking for? Search again!