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Quality Assurance Auditor
Synarc, the world's largest Central Radiology Service dedicated to clinical trials is currently seeking a Quality Assurance Auditor for their corporate headquarters in downtown San Francisco, CA.
Position:QA Auditor
Salary: Competitive
Visa Sponsorship: No
Location: San Francisco
Package: Full medical, 401k, other incentives
Responsibilities:
- Conduct internal quality assurance audits and manage the follow-up on corrective actions deemed necessary.
- Conduct audit of system validation documents
- Organize and/or participate in audits by clients/regulatory agencies and coordinate responses between the audited functions/departments.
- Conduct 3rd party audits (Synarc's service providers)
- Assist in the administration of SOPs, review for GCP compliant
- GCP /21 CFR 11 and OSPRey training of staff
- Act as a GCP / regulations resource for all Synarc staff
- For providing audit reports and other feedback to operational staff pertaining to the quality of work performed (GCP and other criteria).
- For all quality audits performed by clients or agencies at a Synarc office, including the timely response to such audits.
- For communicating standards and performance to the QAD.
- For reviewing SOPs, GCP and regulatory compliance.
Qualifications:
- Graduate in a life science discipline or other academic background.
- Sound knowledge of clinical research, GCP, regulations and at least 3 years in a clinical research environment as an auditor (academic, medical devices, pharmaceutical or CRO).
- The incumbent is subject to matrix management and is expected to master matrix management proficiently.
- Excellent verbal and written command of English.
- Excellent organizational, interpersonal and team skills.
- Excellent analytical skills and the ability to pay attention to detail and to work independently.
- Leadership skills and personal qualities to be successful within a matrix organization.
Synarc offers a competitive salary and benefits, a dynamic work environment working with cutting edge technology and various other perks.
Contact:
Interested qualified candidates can forward their resume/CV to resume@synarc.com. Please refer to position title in the email subject.
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