Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
Ardea is seeking a GCP QA Manager/Senior Associate to join its’ dynamic team.
The successful GCP QA Manager/Senior Associate candidate will focus on managing vendor audits to include: IRB’s, recruitment vendors, Central and EKG Labs. Will provide consultation in interpretation of GCP regulations, guidelines, policies, and procedures; plan and conduct independent Good Clinical Practice (GCP) quality assurance (QA) audits to assess compliance with regulations, training programs, documentation review, guidelines, and operating procedures; evaluate non-conformities and report findings; support GCP QA infrastructure development activities; support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
• Bachelor’s (BS) in the Life Sciences or related discipline.
• At least six to eight years’ demonstrated experience in the GCP responsibilities listed above.
• Strong knowledge of GCP regulations and good documentation practices.
• Past experience working in clinical development is preferred.
• Extensive knowledge of biotechnology research and development processes and regulatory environments.
• Strong writing skills in protocols, SOPs and QA reports.
• Strong knowledge of GLP bio-analytical and dose analysis
• Must have ability to listen, communicate effectively (both orally and in writing) and to interact with all levels within the organization. Excellent reasoning, interpersonal and organizational skills, and superior attention to detail.
• Extensive skills, knowledge and abilities with computers and software programs including Word, Excel, and document management programs.
• The ability to work in a fast-paced and team environment.
• This job may necessitate working outside “regular” work hours.
• Some travel is required.
Ardea Biosciences, Inc. a wholly owned subsidiary of Astra Zeneca based in San Diego is a Biotechnology Company focused on the development of small molecule therapeutics for the treatment of serious diseases.