We are in search of a Quality Assurance Specialist to support our Quality Assurance Director and testing facility management in ensuring compliance with Good Laboratory Practices (GLPs) and adherence to best practices outlined in our Standard Operating Procedures (SOPs).

Responsibilities:

• Collaborate with the QA Director 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 and report audits of study data and reports.
• Evaluate and ensure the accuracy and completeness of our QA document systems.
• Support the evaluation of document control and tracking systems and provide recommendations to optimize document control for Testing Facility Management.
• Conduct 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.
• Deliver GLP training programs to Testing Facility staff.
• Perform audits of subcontracted laboratories and vendors within our facility.
• Offer support, and occasionally lead, external GLP compliance audits of our facility alongside the QA Director.
• Contribute to audits of computer validation requirements, gap analysis, execution scripts, results, and validation reports.
• Stay updated with the latest developments in relevant guidance materials and regulations.
• Attend professional Quality Assurance meetings.
• Adhere to all company policies.

Education/Experience Requirements:

• A bachelor's degree in a life sciences area is required.
• A minimum of 5 years experience in a QA role, ensuring compliance with GLP regulations and 21 CFR Part 58.
• RQAP-GLP certification is preferred.
• Demonstrated knowledge of the preclinical drug development process and the role of QA in supporting these activities.
• Proven ability to lead QA investigations and audits with minimal supervision.
• Demonstrated capability to host and support client and/or regulatory compliance audits.
• Experience in auditing processes for computerized systems is a plus.

Additional Requirements:

• 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, including management, research teams, and sponsors.
• Proficiency in computer use is required.

If you are a dedicated and experienced Quality Assurance Specialist, passionate about maintaining quality standards and committed to upholding the highest levels of compliance, we encourage you to apply. Join our dynamic team and contribute to our mission of excellence in quality assurance.