Quality Assurance Associate

About the Role

As a Quality Assurance Associate, you will play a vital role in safeguarding the integrity of clinical and laboratory research that contributes to the development of new medicines and therapies. This position offers an exciting opportunity to work across multiple areas of a regulated research environment, partnering with scientific, clinical, and operational teams to ensure studies are conducted to the highest quality standards.

What You'll Do

• Conducting audits of clinical and laboratory study activities to verify compliance with protocols, Standard Operating Procedures (SOPs), GxP requirements, and regulatory guidelines.
• Reviewing study documentation, reports, and data to ensure accuracy, consistency, and completeness.
• Partnering with teams across Clinical Operations, Laboratory Services, Data Management, Recruiting, Screening, Bioanalytical Sciences, and other functional areas to support quality initiatives.
• Preparing clear, concise, and actionable audit and inspection reports.
• Communicating audit observations and findings effectively to stakeholders and supporting the development of appropriate corrective actions.
• Verifying that SOPs are current, followed consistently, and aligned with regulatory expectations.
• Participating in a variety of quality activities, including: Study audits, In-life audits, Process audits, Vendor qualifications, Equipment validation reviews, Software validation assessments.
• Identifying trends, risks, and opportunities for process improvements that strengthen quality systems and operational effectiveness.
• Maintaining organized and accurate quality records and audit documentation.
• Interpreting and applying GCP, GLP, and GCLP regulations to support compliant study conduct.
• Collaborating with experienced QA mentors to expand your knowledge and technical expertise.
• Contributing to a culture of continuous improvement, compliance, and operational excellence.

What You'll Need to Succeed

Required Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.
• Basic understanding of pharmaceutical, clinical research, or laboratory environments.
• Familiarity with GCP, GLP, GCLP, ICH guidelines, or other regulated quality systems is preferred.

Skills & Attributes

• Passionate about quality, compliance, and scientific integrity.
• Naturally curious and analytical with strong problem-solving abilities.
• Highly organized and capable of managing multiple priorities simultaneously.
• Detail-oriented with a commitment to accuracy and thoroughness.
• Comfortable reviewing technical documents and identifying inconsistencies.
• Skilled communicators who can confidently interact with cross-functional teams.
• Adaptable and able to thrive in a fast-paced, evolving environment.
• Dependable professionals who demonstrate sound judgment, discretion, and integrity.

Technical Skills

• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Experience with quality management systems, electronic document systems, or laboratory software is an asset.
• Familiarity with MasterControl, Watson LIMS, or Analyst software is considered a plus.