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.
