We are seeking a dedicated Quality Assurance Associate to support our Quality Assurance Unit (QAU) and testing facility management in maintaining compliance with Good Laboratory Practices (GLPs) and company Standard Operating Procedures (SOPs).

Responsibilities:

• Collaborate with the QA Director and/or QA Specialist to support and, at times, lead testing facility QA audits.
• Review study protocols to ensure the inclusion of all necessary elements.
• Provide assistance in inspecting, reviewing, and reporting on critical phases to maintain protocol execution integrity, SOP compliance, and data collection.
• Maintain comprehensive, properly signed, and dated records for each periodic inspection.
• Conduct or support and report audits of study data and reports.
• Conduct or support facility and process audits within the testing facility.
• Review SOPs to ensure alignment with industry best practices and relevant operational considerations in line with GLPs and other facility SOPs.
• Conduct or support GLP training programs for Testing Facility staff.
• Conduct or support facility audits of subcontracted laboratories and/or vendors in collaboration with the QA Director and/or QA Specialist.
• Stay updated with the latest developments in relevant guidance materials and regulations.
• Attend professional Quality Assurance meetings.

Education/Experience Requirements:

• A bachelor's degree in a life sciences area is required.
• A minimum of 1 year of experience in a QA role working in accordance with GLP regulations is preferred; familiarity with 21 CFR Part 58 is a plus.
• Demonstrated knowledge of the preclinical drug development process and associated QA roles.

Additional Requirements:

• Demonstrated ability to adapt to the demands of fast-paced research activities.
• Strong attention to detail and the ability to identify and resolve issues effectively.
• Excellent interpersonal skills and comfort in communicating with various stakeholders through various modes of communication.
• Proficiency in computer use is required.

If you are a diligent Quality Assurance Associate, passionate about upholding the highest quality standards and ensuring compliance with regulations, we encourage you to apply. Join our dynamic team and contribute to our commitment to excellence in quality assurance.

Location:

St. Kitts, West Indies