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Compliance Associate - II
Ref No.: 18-05805
Location: Foster City, California
Regulatory Compliance Specialist - Electronic Systems

Essential Duties and Job Functions:

• Assist members of Electronic System Compliance in providing quality and compliance oversight for the computer system validation and the electronic records / electronic signatures compliance programs
• Conduct electronic record and electronic signature assessments and assist the business areas and IT in developing corrective action plans
• Work to ensure that up-to-date computer system inventories and assessments of regulated systems are maintained
• Assist with CRO/service provider audits, audits of software vendors and in-house audits, any of which may require travel

Education and experience:
• BS with 5 to 7 years of experience
• MS with 4 years of experience

Specific Knowledge and Skills Required:
• Previous experience in the biotechnology / pharmaceutical or related industry implementing and validating computer systems that manage regulated information
• Experienced in the validation of COTS and in-house developed computer systems
• Experienced in prospective and retrospective computer system validation
• Experienced in performing 21 CFR Part 11 and Annex 11 assessments (gap analyses) and developing corrective action plans
• Knowledgeable with software development life cycles and other IT related development practices
• Working knowledge of IT infrastructure qualification processes and IT operating procedures
• Experienced in using, implementing, and/or validating systems, such as: drug safety, medical/drug coding, clinical trial management, clinical information, electronic data capture, electronic diary, radiological reading, laboratory information management, computerized laboratory instrumentation, document/enterprise content management, submission publishing, electronic transfer/exchange, structured product labeling, training records, CAPA, and audit tracking
• Experienced in developing procedures for validation, electronic record and electronic signature compliance, electronic systems compliance, and/or IT operational procedures
• Knowledgeable in 21 CFR Part 11, GCP, GLP, and GMP regulations .