Senior Quality Assurance Specialist

Quality Assurance Specialist – USA, Remote - July start – $70-100K USD

Permanent full-time – Biotech

Goodland Pharma, your dedicated recruitment partner in the Life Sciences sector, is thrilled to offer an exceptional opportunity for a Quality Assurance Specialist to join a leading organisation in translational and preclinical research.

While this role is primarily aimed at senior candidates, we are also open to reviewing applications from junior candidates with 1-2 years of relevant experience.

The opportunity:

Join a dynamic team committed to advancing therapeutic discovery and development programs. As a QA Specialist, you will ensure that research activities and infrastructure conform to the highest standards.

This biotech is a world leader in translational research with over 50 years of translational R&D experience. They collaborate with large pharmaceutical and biotechs to advance a wide range of therapeutic programmes.

Your role:

• Lead QA audits of the testing facility in collaboration with the QA Director.
• Review study protocols to ensure all required elements are included.
• Inspect, review, and report on critical phases to ensure protocol integrity, SOP compliance, and accurate data collection.
• Maintain detailed and signed records of periodic inspections.
• Conduct and report study data and report audits.
• Evaluate and ensure the accuracy and completeness of QA document systems.
• Support the evaluation of document control and tracking systems, providing recommendations for optimisation.
• Conduct facility and process audits of the testing facility.
• Review SOPs for alignment with best practices and GLP requirements.
• Conduct GLP training for testing facility staff.
• Audit subcontracted laboratories and vendors.
• Lead and support external GLP compliance audits.
• Support audits of computer validation requirements, including gap analysis, execution scripts, and validation reports.
• Stay updated on relevant regulatory guidance and participate in professional QA meetings.

What you bring:

• A bachelor’s degree in a life sciences area.
• Minimum of 5 years’ experience in a QA role, preferably in accordance with GLP regulations
• Demonstrated knowledge of the preclinical drug development process and the role of QA.
• Proven ability to lead QA investigations and audits with minimal supervision.
• Experience hosting and supporting client and/or regulatory compliance audits.
• Experience in auditing processes for computerised systems is preferred.
• Adaptability to fast-paced research activities and strong interpersonal and computer skills.

For junior candidates:

• A bachelor’s degree in a life sciences area.
• 1-2 years of experience in a QA role
• A willingness to learn and grow in a fast-paced research environment.

Join us:

If you're ready to make a significant impact in the field of life sciences and ensure the highest standards of research quality, we want to hear from you. Apply today through Goodland Pharma with your CV and a brief cover letter highlighting your QA expertise and your motivation for looking for a new role.