Quality Assurance Specialist

We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.

What fuels our focus? Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. We show up every day committed to do work that matters. When you join ProTrials, you will join a collaborative community helping to build a healthier world.

We also understand your need to balance a meaningful workload with life’s every-day moments. At ProTrials, we know that this makes our employees happier, healthier, and more successful.

ABOUT THE JOB:

The QA Specialist ensures corporate operations align with FDA, ICH, and GCP regulations by conducting audits, monitoring quality systems, and proactively identifying and resolving compliance issues. This role oversees controlled documents and training systems, supports inspection readiness, and partners cross-functionally to drive CAPA activities and continuous improvement. With strong knowledge of regulated clinical research environments, the QA Specialist provides quality oversight, metrics analysis, and ongoing support to strengthen compliance and operational excellence across the organization.

HERE IS WHAT YOU WILL DO:

• Assess, evaluate and review corporate operations against GCP regulations to assure real-time observation of activities, issue identification/ resolution, including proper and timely documentation
• Facilitate and conduct internal and external audits and provide metrics and analysis of trends based on audit findings
• Assist in the conduct or arrangement of GCP training for all staff
• Maintain the Controlled Document and Training systems and oversee administrative support utilized in maintaining systems
• Manage and track controlled documents from the Document Change Control Form (DCRF) until document approval or retirement, including updating related controlled document, training logs, and trackers
• Provide quality oversight to the revision, review, and approval of controlled documents
• Work with document reviewers to advise and revise controlled documents as appropriate and ensure reviews are performed in a timely manner
• Provide input and support the creation of new controlled documents
• Identify gaps in controlled documents and recommends solutions
• Communicate effectively across departments on status of controlled documents and corporate training
• Participate in inspection readiness activities and corporate audits, sponsor audits and/or regulatory inspections
• Work closely with others to determine root cause and potential preventive/corrective actions in support of the corporate CAPA Program
• Assist with the evaluation of learning management systems and other QA technology
• Assist in the preparation of quality metrics and reports
• Assist QA management team with other clinical QA activities as required

HERE IS WHAT YOU BRING TO THE TABLE:

• Good working knowledge of FDA, GCP, and ICH regulations, guidelines, and standards governing regulated clinical research and good documentation practices is required
• Experience working in a GCP environment
• Strong understanding of Quality Assurance practices and systems

HERE IS WHAT WE OFFER:

• Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family.
• We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally.
• You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals.
• At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward.
• We have the best coworkers, if we do say so ourselves.