QA Advisor III

Resolian – Your global bioanalytical, biomarker and analytical sciences partner supporting all phases of your drug development. Resolian is a leading global Contract Research Organization (CRO) providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic (DMPK), and GMP CMC analytical and materials science.  Its team of more than 400 experts across the US, UK, and Australia, Resolian supports pharma and biotech companies’ programs throughout the entire drug development continuum.

• · 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