Associate 2, QA Change Control - United States
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- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
This position reports to the Quality Assurance Change Control Senior Manager and will be responsible for activities related to oversight of proposed changes to GxP systems as well as contributing to oversight and maintenance of the change control system, product changeover, and plant shutdown activities.
- Provide QA oversight of change control documentation including; review and approval of change requests, tracking of implementation requirements, and managing documents supporting the change control process.
- Ensuring all proposed changes adhere to company policies/procedures and GMP regulations and are reviewed by applicable stakeholders.
- Provide status reports, including relevant metrics, to department management and follow up on open change requests to ensure timely completion. Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the company and for change control and multi-product approaches utilized at our company.
- Provide QA oversight of manufacturing product changeover and shutdown activities, which includes gowning required to enter manufacturing areas. Facilitate cross functional meetings to ensure proposed changes are communicated to and discussed by relevant stakeholders.
- Represent the change control program in internal/external audits and regulatory inspections.
- Ability to comprehend technical information related to changes and regulatory expectations.
- Working knowledge of United States and European regulatory requirements, guidelines, and recommendations for change control.
- Exhibited proficiency working within quality systems.
- Ability to lead cross-functional initiatives to completion.
- Ability to successfully communicate with representatives from all levels within the organization.
- 6+ years of experience in a GMP regulated environment.
- Exhibited proficiency working within change control systems.
- Understanding of Ex-US and European regulatory guidelines.
- Experience with TrackWise Quality Management System.
- Experience and proficiency with standard office software applications, including MS Word, MS Excel, MS Project, and MS Powerpoint.
BA or BS in a technical discipline (physical or biological sciences preferred).
This position will require interaction with all levels (up to Senior/Executive Management) in Technical Operations, Clinical Operations, Pharm/Tox, Regulatory, R&D, Business Operations, Finance, Information Technology, and Administration.
This position has no supervisory responsibility.