Title: Contract Clinical Quality Assurance Specialist
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.
This position will support the Clinical Quality Assurance program to ensure clinical trials are conducted in accordance with relevant regulations, guidelines, procedures and protocols. The successful applicant will be able to independently drive tasks and projects and work collaboratively with cross functional teams. A combination of work experience and knowledge of GCP and regulatory requirements is preferred.
These may include, but are not limited to, the following; other duties may be assigned
- Maintain all associated CQA department spreadsheets tracking of deviations, CAPAs, complaints, audit schedule/findings, and audit files as applicable (Clinical Trial Audit Tracker)
- Independently schedules, coordinates vendor/supplier audits, internal audits, compliance visits, for-cause audits, and clinical trial site audits.
- Assist in preparation of required documentation to support audit activities including; audit plans, audit reports, audit certificates, and corrective action plans
- Assist in the generation of metrics, status and other information in relation with GCP as required by management.
- Ensure elements and format of CQA SOPs are in compliance with FSI standards.
- Assists senior staff during regulatory inspections or other audits.
- Perform other duties as assigned
Education & Experience:
- Minimum of 3 years of experience in a GCP-Biologics or Pharmaceutical environment
- Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
- Strong problem solving and analytical skills with demonstrated ability to be detail-oriented; while managing multiple projects simultaneously
- Strong communication skills (written and verbal)
- Position may require occasional evening and/or weekend commitment
- Position may require working with biological and/or chemical hazards
- Position may require occasional travel (~25%), domestic and international