Jt555- Change Control Specialist

• Change Control Specialist to support change management activities within a regulated pharmaceutical manufacturing environment.
• Responsible for coordinating and maintaining change control documentation and workflows, ensuring compliance with GMP, quality systems, and internal procedures.
• Manage and coordinate Change Control records in the quality management system to ensure proper documentation and timely completion.
• Create, review, route, and track change control documentation through approval workflows.
• Maintain compliance with cGMP, GDP, and regulatory requirements related to change management.
• Support cross-functional teams including Quality, Manufacturing, Engineering, and Validation during change control activities.
• Ensure documentation accuracy, completeness, and traceability within the change management process.
• Monitor change control progress and follow up with responsible stakeholders to ensure timely closure.
• Generate reports and metrics related to change management performance and compliance.
• Support preparation for internal audits, regulatory inspections, and quality assessments.
• Maintain proper electronic records in systems such as TrackWise or other quality management platforms.
• Provide administrative support related to quality systems documentation and record management.

• Bachelor’s Degree in Science or related field preferred.
• 5+ years of experience supporting quality systems, change control, or documentation management in a regulated environment preferred.
• Bilingual (English / Spanish) – ability to read and understand technical documentation in English.
• Experience supporting Change Control processes within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Knowledge of cGMP regulations, documentation practices, and quality systems.
• Experience working with TrackWise or similar Quality Management Systems (QMS).
• Ability to manage multiple tasks and coordinate with cross-functional teams.
• Strong communication and problem-solving abilities.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Available for remote and administrative shift.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.