Virscio is seeking a Quality Assurance Associate to support the QAU 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 Associate will perform and support the conduct of study and facility QA audits, review of facility training records, maintenance logs, and SOPs. The QA Associate will also support facility and vendor audits as well as assisting with GLP training programs.

 

Responsibilities

 

·   Support and/or lead testing facility QA audits in concert with the QA Director and/or QA Specialist.

·   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 or support and report study data and report audits.

·   Conduct or support 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 or support GLP training of Testing Facility staff.

·   Conduct or support facility audits of subcontracted laboratories and/or vendors in concert with the QA Director and/or QA Specialist.

·   Maintain familiarity with the latest updates to relevant guidance materials and regulations.

·   Attend professional Quality Assurance meetings.

 

Education/Experience Requirements

 

• Requires bachelor’s degree in a life sciences area.

• Minimum of 1 year experience in a QA role working in accordance with GLP regulations, 21 CFR Part 58 preferred.

• Demonstrated knowledge of preclinical drug development process and associated QA roles.

 

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