QA Advisor III
Resolian 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