Quality Assurance Specialist

Role Overview

• Responsible for assessing, evaluating, and reviewing corporate operations against GCP regulations to assure real-time observation of activities, issue identification/ resolution, including proper and timely documentation
• Facilitates and conducts internal and external audits and provides metrics and analysisof 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 process and tracks controlled documents from the Document Change Control Form (DCRF) process until document approval or retirement, including updating related Controlled Document, training logs, and trackers
• Responsible for providing 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
• Responsible for providing input and support as appropriate to the creation of new controlled documents
• Works with QA Management and other departments to identify gaps in controlled documents and recommends solutions
• Communicate effectively with staff and management across departments on status of Controlled Documents and corporate training
• Participate in inspection readiness activities and corporate audits, sponsor audits and/or regulatory inspections, as required
• Works closely with others to determine root cause and potential preventive/corrective actions in support of the corporate CAPA Program. Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations. Ensure support for the timely closure of investigations
• Assist QA management with the evaluation of learning management systems and other QA technology, as required
• Assist in the preparation of quality metrics and reports
• Assist QA management team with other Clinical QA activities as required
• Other duties, as assigned

Requirements

• 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
• High level of computer/software proficiency and adaptability
• Exceptional attention to detail
• Ability to prioritize multiple daily tasks to meet timelines
• Strong understanding of Quality Assurance practices and systems
• Strong independent judgement and decision-making abilities
• Outstanding interpersonal, oral, and written communication skills and attention to detail
• Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner
• Available to travel up to approximately 25% of the time

Tech Stack

• Google Cloud Platform

Benefits

• 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.