Change Control Specialist - West Point, United States - AA2IT

Description

Job Description

Job Description


Preferred Experience and Skills:

• Strong understanding of Change Control and Project management
• Demonstrated ability to work both independently and as a part of a team
• Strong technical problem-solving abilities
• Strong collaboration skills
• Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment
• Experience with introduction of process changes to a licensed process

Project Management skills as they will lead their own small projects utilizing Change control systems.


Education Minimum Requirement:
Bachelor's Degree in Engineering or Science Required Experience and Skills:

• Minimum of two (2) years of work experience in the biological/

pharmaceutical/chemical

manufacturing industry

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role.
• Minimum of six (6) months' work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing.

Responsibilities:

The Specialist is responsible for technical support and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture.

In this role, the contracted person will work as an individual contributor, may act as a team or project lead and lead work of others as required, as well as contribute to the performance and results of a department.

Additionally, this individual will provide technical guidance and anticipate and interpret needs to identify and implement solutions.

Additional responsibilities include:

• Establish and manage project schedules and timelines
• Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
• Responsible for stakeholder engagement, communication, and risk escalation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
• Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Consistent application of standardized work, engineering, and process tools (i.e. TrackWise, IPI, MS Project, Excel).
• Provide technical support to manufacturing for problems and issues.
• Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.

Company Description AA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.

AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.

Company Description

AA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value.

We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.\r\rAA2IT is a global firm providing Staffing and IT Solutions.

We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.
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