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Epic Sciences is Seeking a Quality Assurance Specialist to Join the Team
SAN DIEGO, California - 02/08/2012
Quality Assurance Specialist GLP
Job Description
Key Responsibilities:
- Assist in writing and reviewing Quality Assurance Standard Operating Procedures including reviewing for compliance with principles of GLP and OECD standards
- Responsible for the document control system including document review, approval and release and archiving activities
- Fulfill the role of Archivist responsible for the maintenance of sample and record archives
- Review and approve equipment qualification protocols, calibration and maintenance records and maintain the Equipment History Files
- Maintain staff training records
- Maintain the Master Schedule
- Reviews Study Plans for compliance with GLP and OEDC where required
- Maintain copies of current protocols for assign studies
- Audit study reports to assure that the reports comply with applicable regulations, describe the study methods and accurately reflect the data
- Prepare and sign Quality Assurance statements as required to be included in audited final reports
- Schedule, track and conduct procedural audits, facilities inspections and computer validation audits
- Report all audit findings to management and Study Director (where applicable)
- Advise management of any deficiencies in Regulatory Requirements
- Liaise with company personnel to ensure a full understanding of regulatory requirements
- Assist with and participate in Sponsor and Regulatory visits as appropriate
- Perform administrative tasks as required
This position will start as part-time, but will eventually become full-time.
No relocation.
Desired Skills and Experience
Qualifications and Experience:
- A relevant scientific degree
- A minimum of three years experience of working in a QA role for GLP (Good Laboratory Practices) in a bioanalytical laboratory
- Quality assurance auditing experience in a bioanalytical environment is preferred
- GCP (Good Clinical Practice) knowledge would be beneficial
- Diligent and a team player with excellent attention to detail
Company Description
Epic Sciences, Inc. ("Epic") is a cancer diagnostics company built around its premiere platform to identify and characterize rare cells including circulating tumor cells ("CTCs"). Epic's mission is to improve cancer management by providing easily accessible real-time biopsy material over time from individual patients. Epic's platform is ideally suited for protein and nucleic acid characterization of CTCs. As a result, Epic is currently working with its multiple Pharma partners to develop companion diagnostic tests which will lead to faster and cheaper clinical trials with higher probabilities of success. Ultimately, Epic will facilitate the dream of personalized medicine by enabling physicians to provide the right drug to the right patient at the right time.
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