Change Control Coordinator- QS Specialist III

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Job Responsibilities:

• Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals..
• Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations. m
• Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS expectations.
• Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly.
• Supports management and monitoring of change records for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases.
• Supports management review process through development and generation of quality system metrics and trending, and escalates issues as required.
• Supports the maintenance and improvement of quality systems processes, as needed.
• Works directly with operating entities and internal clients to ensure follow-up of change tasks.
• Participate in compliance audits as required.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
• Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
• Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.

Knowledge & Skills:

• Will need to demonstrate the ability to manage multiple change controls of varying complexity and scope of tasks in a fast-paced environment to meet timelines.
• Demonstrates proficiency in Good Manufacturing Practices (GMPs)
• Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.
• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
• Demonstrates Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively.
• Demonstrate strong scientific/technical understanding of small and/or large biologic molecule operations and related regulations/guidelines.
• Demonstrates knowledge of Six Sigma andLEAN concepts, and risk management tools for assessing change impact.
• Demonstrate knowledge and application of risk management principles, including identification, controls, mitigations, and actions.
• Demonstrates excellent verbal and written communication skills to all levels of the organization. Technical writing skills required.
• Demonstrate ability to problem solve and lead process improvements.
• Demonstrate ability to lead cross-functional meetings and make decisions as QA representative.
• Demonstrates strong interpersonal skills with ability to influence, negotiate, manage conflict, and negotiate.
• Demonstrates proficiency in Microsoft Office applications.

Education and Experience:

• 5+ years of relevant experience in a GMP environment for biologics manufacturing and a BS or BA, with change control experience a must. (OR)
• 3+ years of relevant experience and a MS.