Address
Form of workVirscio is seeking a Quality Assurance Specialist to support the QA Director and testing facility management in ensuring research activities, animal care, and infrastructure conform to Good Laboratory Practices (GLPs) and best practices stipulated in company Standard Operating Procedures (SOPs). The QA Specialist will perform and support the conduct of study and facility QA audits, review of facility training records, maintenance logs, SOPs, and computerized systems validations. The QA Specialist will also support facility and vendor audits as well as providing GLP and QA training programs.
Responsibilities
Support and/or lead testing facility QA audits in concert with the QA Director.
Review study protocols to confirm that all required elements are included.
Support the inspection, review, and reporting of critical phases adequate to assure the integrity of protocol execution, SOP compliance, and data collection.
Maintain a written and properly signed and dated record of each periodic inspection.
Conduct and report study data and report audits.
Evaluate and ensure the accuracy and completeness of the QA document systems.
Support evaluation of document control and tracking systems, and definition of associated recommendations for Testing Facility Management regarding optimizing document control.
Conduct facility and process audits of the testing facility.
Review SOPs to ensure alignment with best practices and relevant operational considerations in accordance with GLPs and other facility SOPs.
Conduct GLP training of Testing Facility staff.
Conduct facility audits of subcontracted laboratories and/or vendors.
Support and/or lead outside GLP compliance audits of the facility in concert with the QA Director.
Supports audits of computer validation requirements, gap analysis, execution scripts, results, and the validation report.
Maintain familiarity with the latest updates to relevant guidance materials and regulations.
Attend professional Quality Assurance meetings.
Comply with all company policies.
Education/Experience Requirements
Requires bachelor's degree in a life sciences area.
Minimum of 5 years' experience in a QA role working in accordance with GLP regulations, 21 CFR Part 58.
RQAP-GLP certification preferred.
Demonstrated knowledge of preclinical drug development process and the role of QA in supporting these activities.
Demonstrated ability to lead QA investigations and audits with minimal supervision.
Demonstrated ability to host/support client and/or regulatory compliance audits.
Experience auditing processes for computerized systems preferred.
Additional Requirements
Demonstrated ability to adapt to the necessities of fast-paced research activities.
Attention to detail and ability to identify and resolve issues effectively.
Strong interpersonal skills and comfort interacting with Virscio management, research team and Sponsors through various modes of communication.
Strong computer literacy required.
Location
St. Kitts, West Indies
