Our Biotech client is seeking a Quality Change Control Manager who will be responsible for supporting the development and implementation of Change Control activities in ACE system. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. The successful candidate is proficient in communication (written and verbal), multi-tasks across multiple functional areas, is timeline focused and flexible in their work scheduling to meet the demands of a growing Minaris organization.

• Coordinate and conduct CRB (Change Control Review Board) meetings to discuss requested changes.
• Responsible for coordinating changes across the various support teams, ensuring correct procedures are followed and changes are accurately recorded documented and proper impact assessment completed
• Collaborates with other departments to ensure proper documentation and approvals are obtained according to the type of change
• Collaborates with area managers and subject matter experts to design, develop and update processes and requirements needed for change managements evaluations
• Managing the day-to-day activity within change control, in accordance with the change control policy and process.
• Responsible for managing all request for change within the ACE system and they are documented properly.
• Review the requested change and ensuring pre-requisites are completed fully and correctly.
• Function as the Change Management expert in the system. Provide support and guidance to employees and conduct end-user electronic system training, as needed
• Reviews change requests for completeness, from documentation to post-implementation review and takes necessary actions to ensure compliance and minimize risk.
• Report change information to internal and external customers, auditors and/or inspectors upon request
• Support the development and implementation of a global Quality System change control system.
• Assist in developing and implementing processes, policies, and procedures governing the global Quality System
• Develops metrics for Quality Management Reviews

REQUIREMENTS

• BS in biological sciences or other relevant field of study
• 5+ years’ experience in QA in a life sciences company with a strong focus in the Quality Management System regulations and requirement
• Strong Change Control experience including creating, reviewing and managing Change Controls
• Experience leafing Control Review Board meetings
• Experience in the automated Quality Systems workflows for Change Controls.
• Experience in both clinical and commercial manufacturing is preferred.
•  Experience in authoring, reviewing, and /or approving change control and other quality system documents.
• Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
• Experience participating in or hosting health authority inspections and/or client audits.
• Detail-oriented and organized
• Analytical and problem-solving skills
• Good written and oral communication skills
• Ability to multi-task and be adaptable
• Flexible and able to adapt to company growth and evolving responsibilities
• Excellent judgment, decision-making skills, and the ability to work under continual deadlines and pressure
• Self-motivated, and has a positive attitude.
• Must be able to work during the weekend, holidays and as required by the company
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc.
• Understanding of quality system applications
• Must be able to handle the standard/moderate noise of the manufacturing facility.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey.

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