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Onyx Pharmaceuticals, Inc.
Clinical QA Auditor/Senior Auditor
Location: Emeryville,
California-Oakland/East Bay
94608
Posted on:
10/7/2009 4:41:24 PM
Postion type:
Full time
Job Code:
420-0012-09
Required Education:
Bachelor's Degree
Salary:
DESCRIPTION
DEPARTMENT: Regulatory Affairs
REPORTING TO: Director, Quality Assurance
POSITION SUMMARY:
This auditing position leads and directs clinical quality assurance audits and related activities for the Regulatory Department in the Development Organization. CQA Auditors are involved in all aspects of clinical development from protocol development to the final clinical report and regulatory submissions. Additional areas of involvement include Computer System development, Electronic Data Capture systems, CRO selection, and vendor management.
RESPONSIBILITIES:
• Attend project meetings and special topic committees to develop project-specific audit plans and timelines.
• Serve as lead auditor, as assigned, in multi-auditor situations; assist with the training of junior auditors.
• Plan and perform compliance audits of foreign and domestic clinical investigators, contract clinical laboratories, and other suppliers or third-party vendor facilities supporting Onyx Clinical projects.
• Perform and document audits of clinical databases, procedures and systems related to data management services
• Provide QA review of project-specific documents, as needed.
• Communicate actionable findings to various staff levels. Present findings to ensure clear understanding of deficiencies (verbal and written) and collaborate with project team to develop adequate corrective and preventative action plans.
• Prepare investigational sites for regulatory inspections (routine and for-cause) of studies monitored by Onyx and assist in liaison activities with regulatory agency during investigator and/or sponsor/monitor inspections.
• Oversee the distribution, filing and retention of audit documentation associated with assigned projects and tasks.
REQUIREMENTS:
QUALIFICATIONS:
EDUCATION/CERTIFICATIONS/LICENSES
Bachelors Degree (BA/BS), from an accredited college or university
EXPERIENCE
• Four years QA experience or combined experience of at least 5-7 years in pharmaceutical product development and/or quality assurance
• Experience in GCP required, preferably experience in oncology.
• Auditing experience required
KNOWLEDGE, SKILLS, AND ABILITIES
• Strong knowledge and demonstrated practice of ICH/GCP Guidelines
• Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.
• Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure
• Must be highly organized and possess excellent attention to detail
• Motivated, self directed, able to work autonomously and have a proven ability to work in a team environment
• Ability to travel up to 50% both domestic and international
• Candidates based outside of the Bay Area can be remote from the home office located in Emeryville
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