The Change Control Specialist administers, coordinates, and executes the site Change Control program in support of cGMP pharmaceutical and aseptic manufacturing operations. This role ensures that proposed changes to facilities, equipment, utilities, computer systems, manufacturing processes, procedures, analytical methods, materials, and quality systems are thoroughly assessed, properly documented, formally approved, effectively implemented, and successfully closed in compliance with regulatory requirements and internal quality standards. The position focuses on conducting impact assessments, facilitating cross-functional review and approval workflows, driving timely implementation of changes, and maintaining inspection-ready documentation aligned with quality system activities such as change control, deviation management, CAPA, risk assessment, and overall quality system compliance.
Serve as the primary coordinator for site Change Control records from initiation through closure, ensuring each change is managed consistently and in alignment with quality system requirements.
Review and process change requests involving manufacturing operations, facilities, utilities, equipment, computerized systems, quality systems, materials, documentation, and validation activities.
Facilitate cross-functional impact assessments to determine potential effects of proposed changes on product quality, regulatory commitments, validation requirements, training needs, and operational performance.
Ensure change control records include clear justification, documented risk assessments, detailed implementation plans, defined effectiveness measures, and complete supporting documentation.
Monitor change control timelines, proactively identify risks to on-time completion, and drive overdue actions to closure through follow-up, coordination, and escalation when necessary.
Coordinate extension requests and escalation activities when implementation timelines are at risk, ensuring appropriate approvals and documentation are in place.
Partner with Manufacturing, Validation, Engineering, Quality Control, Regulatory Affairs, Supply Chain, and Technical Services to evaluate, plan, and implement changes in a controlled and compliant manner.
Support the site's Quality Management System (QMS) by ensuring adherence to internal procedures, regulatory expectations, and established quality processes related to change control.
Participate in continuous improvement initiatives focused on change management effectiveness, quality metrics, and process efficiency, recommending enhancements based on data and trends.
Maintain inspection-ready documentation and electronic records for all change control and related quality system activities, ensuring accuracy, completeness, and traceability.
Lead or facilitate quality impact assessments and risk evaluations using established risk management tools to determine potential effects on product quality, patient safety, data integrity, and regulatory commitments.
Determine appropriate change classification and define validation, qualification, and documentation requirements based on risk, regulatory expectations, and internal standards.
Ensure ongoing compliance with cGMP regulations, FDA guidance, ICH requirements, and applicable industry standards in all change control activities.
Review and approve SOPs, protocols, reports, specifications, and other GMP documentation associated with change implementation to confirm consistency, clarity, and compliance.
Coordinate training requirements generated by approved changes, ensuring impacted personnel receive appropriate instruction and that training is documented.
Ensure proper documentation of implementation activities, verification steps, and evidence of effectiveness for each change, maintaining clear audit trails in electronic quality systems.
Maintain accurate records and reporting within electronic quality management systems, supporting data integrity and timely access to information.
Support internal audits, regulatory inspections, and customer audits by preparing relevant change control documentation and quality system information.
Present change control records and related quality system information during inspections and audits, responding to questions and requests for evidence.
Assist with responses to audit observations related to change management activities by providing documentation, clarifications, and corrective action input as needed.
Track and report key performance indicators related to the Change Control program, including timeliness, effectiveness, and compliance metrics.
Identify trends and recurring issues revealed by change control metrics and records, and recommend or support process improvement activities to address root causes.
Generate periodic management reports on change control status, performance, and compliance metrics to support decision-making and continuous improvement.
At least 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or aseptic manufacturing environment.
Hands-on experience supporting Quality Systems, Quality Assurance, Change Control, CAPA, Deviations, or Validation programs.
Strong understanding of cGMP requirements and FDA regulations applicable to pharmaceutical and aseptic manufacturing operations.
Experience performing quality impact assessments and risk evaluations using formal risk management tools and methodologies.
Excellent organizational skills with the ability to manage multiple change records, timelines, and priorities simultaneously.
Strong written communication skills, including the ability to draft, review, and approve clear and concise technical documentation.
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and related tools used for documentation and reporting.
Experience working with electronic quality management systems for change control, documentation, and record maintenance.
Attention to detail and a high level of accuracy in reviewing and maintaining GMP documentation and electronic records.
Ability to collaborate effectively with cross-functional teams such as Manufacturing, Engineering, Validation, Quality Control, Regulatory Affairs, Supply Chain, and Technical Services.
This role operates primarily in an office environment within a GMP-regulated pharmaceutical or aseptic manufacturing setting. The position involves extensive work with electronic quality management systems, Microsoft Office tools, and GMP documentation, requiring sustained focus on accuracy and compliance. Although most activities occur at a desk, the Change Control Specialist regularly moves throughout the facility to collaborate with subject matter experts in Manufacturing, Engineering, Validation, Quality Contro
