QA Advisor III

• • Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
  • Effectively demonstrates behaviors and performance characteristics as described in our core values
  • Demonstrates effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, across the organization, and externally with Regulators and Sponsors
  • Maintain and demonstrate critical thinking, troubleshooting and time management skills aligned with the needs of the operational area
  • Demonstrates full understanding of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and effectively applies; provides accurate guidance and advice on regulatory requirements
  • Ensures that operational area is clean and inspection ready at all times
  • Independently and accurately audits documents against regulatory requirements and verify lab tasks are performed in accordance with ALCOA++
  • Independently and effectively audits laboratory documents and notebooks (e.g., plans, experiment/sample runs, validation files, reports, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations
  • Independently and accurately audits computer systems, facility operations, and other non-study regulated activities
  • Effectively assists in reviewing the Master Schedule as needed
  • Maintains and demonstrates ability to accurately identify non-compliance and deviations; assist with resolution as required
  • Accurately identifies and effectively escalates data integrity and non-compliance issues with Management
  • Independently and accurately audits system audit trails
  • Effectively authors and independently reviews draft templates and SOPs
  • Actively participates and/or hosts Sponsor audits as required
  • Effectively perform vendor qualifications and audits with minimal oversight
  • Effectively executes internal audits/self-inspection programs against agreed upon schedules
  • Independently participates in process improvement initiatives
  • Accurately tracks and presents quality metrics with minimal oversight
  • Actively supports delivery of quality training for employees as needed
  • Independently and effectively executes training of new staff members as needed
  • Actively supports quality events (deviation investigations, OOS, Change Control and/or CAPAs) to completion
  • Effectively assists in the review and evaluation of procedures (e.g. SOPs) to improve quality and efficiency

Skills, Education & Qualifications

• BA/BS or higher; all experiences will be evaluated
• 6+ years experience in GxP Environment, all experiences will be evaluated
• Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP
• Prior CRO Lab Experience a plus
• Familiar with pharmaceutical or biotechnology industry
• Able to review detailed data and documents
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment

US- QA Auditor I,II or III