Change Control Coordinator Premier Care Industries - 3.3 Hauppauge, NY Job Details Full-time $40,000 - $50,000 a year 2 days ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Customer communication Change management Schedule management Continuous improvement Attention to detail Managing projects Delegation Full Job Description The Change Control Coordinator is responsible for managing and coordinating the end-to-end change control process within a contract manufacturing (CMO) cGMP environment, using the company's electronic quality management system (eQMS) as the primary system of record. This position requires strong project management capabilities and the ability to coordinate across multiple functions while supporting both internal stakeholders and external customers. The Coordinator plays a critical role in maintaining timelines, ensuring transparency, and supporting regulatory compliance across a diverse product portfolio, leveraging automated workflows and system-generated tracking rather than manual follow-up alone. Key Responsibilities

• Coordinate and manage change controls from initiation through closure, including both internal and client-initiated changes
• Initiate change control events in the eQMS (Qualio) and assign tasks to the appropriate functional owners (QA, Manufacturing, Engineering, Validation, R D, Regulatory, Stability, Labeling)
• Drive timelines by monitoring system-generated due dates, task status, and automated reminders, and by following up directly with cross-functional teams on outstanding items
• Serve as a central point of coordination between QA, Manufacturing, Engineering, Validation, R D, and Customer Service
• Ensure all required impact assessments (quality, regulatory, validation, stability, labeling, etc.) are assigned to and completed by their designated owners, and confirm completeness prior to closure — this role tracks and verifies completion but does not complete or approve impact assessment content itself
• Monitor eQMS dashboards and reports to identify overdue tasks, aging change controls, and cross-functional bottlenecks
• Identify risks to timelines and escalate delays to management according to defined escalation triggers (e.g., task overdue beyond a set threshold)
• Maintain the accuracy and integrity of change control records within the eQMS, including status, task assignments, and supporting documentation
• Support audits and regulatory inspections, including generating change control records, reports, and responses directly from the eQMS
• Assist in improving change control workflows, system templates, and overall process efficiency, including configuration of eQMS task routing and notification rules Qualifications
• Bachelor's degree in a scientific, engineering, or related field preferred or 2+ years of experience in a cGMP-regulated environment
• Experience in Change Control, Quality Systems, or project coordination required
• Hands-on experience with an electronic quality management system (eQMS) required
• Demonstrated ability to manage multiple projects and timelines simultaneously
• Experience supporting client-facing activities or cross-company coordination preferred Key Skills & Competencies
• Strong project management and coordination skills
• Proficiency with eQMS platforms and comfort configuring or navigating automated workflows, task assignments, and system dashboards
• Ability to manage high-volume, fast-paced change environments
• Excellent communication and follow-up skills, including client-facing professionalism
• Ability to influence cross-functional teams and drive accountability without direct authority
• Detail-oriented with a solid understanding of cGMP and regulatory expectations Join us in a role that champions precision, compliance, and continuous improvement!

Your expertise will be instrumental in safeguarding product quality while supporting innovative development efforts—making a real impact every day!

Pay:

$40,000.00 - $50,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person