Layer, Chiang, et al. Genome Biology
Covance is continuing to grow our Quality Assurance Team!
- Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
- Assure that audits assigned are completed on time and within budget, including audit reporting and CAPA follow up and closure.
- act as a Lead Auditor
- participate in audits, as assigned, according to applicable SOP(s) and the global audit plan
- identify non-conformances with requirements and provide suitable recommendations
- assure that audit reports are completed in a timely manner and that audit results are communicated to auditees and management
- ensure suitable responses to CAPAs are provided by auditees within the agreed timeframe
- escalate to QA management where resolution of audit findings are inadequate
- follow up and closure of audits and CAPAs within agreed timeframe
- maintain all audit and CAPA tracking systems
- serve as a backup auditor to other QA&C staff
- Special Projects
- participate in QA projects
- support special projects requiring QA input
- Quality Assurance
- act as Global QA Lead or Backup on assigned projects, providing GxP advice and QA oversight for project teams
- contribute to process improvement initiatives across organization
- provide support to maintain global quality system to recognized standards
- participate in development of QA processes and SOPs
- support development of processes and SOPs by process owners outside QA
- *Liaison / Representation
- represent QA on project teams, and other internal forums
- represent QA at client meetings and/or audits
- University/college degree (life science preferred)
- BA/BS or equivalent experience
Experience Minimum Required:
2 Years of experience in Clinical Quality Assurance, preferably with GCP experience.
3 Years of experience in other professional roles within pharmaceutical/CRO environment.
Other required work-related experiences:
- Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
- Financial understanding of global clinical development budgets
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Knowledge of the drug development process from the perspective of a contract research organization
Core and Leadership Level
- Strong analytical skills
- Knowledge, understanding and experience in applying ICH/FDA Good Clinical Practices
- Excellent oral, written and presentation skills
- Excellent planning and organizational skills
- Proven interpersonal skills
- Demonstrated ability to handle multiple competing priorities across clinical operating units
- Ability to function as a member of a global clinical team
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.