Quality Laboratory Systems Specialist

* Reporting to the Wilmington Laboratory Lead, the Laboratory System Specialist will support the development of the Laboratory Quality Management System (QMS) for the Wilmington laboratory.
* This will involve the use of the company's Research Laboratories Clinical Supplies QMS and the our company's Manufacturing Division Commercial QMS to develop a local QMS in support of the scope of analytical work to be completed at the Wilmington laboratory.
* Post laboratory start up the role will support ongoing maintenance and change control for the Wilmington laboratory QMS.
* Support the development of a Laboratory QMS to bring together the research division's Clinical Supplies and the manufacturing division's Commercial QMSs into a single laboratory QMS;
* Identify the full scope of work of the laboratory
* Understand the regulatory compliance guidelines that will be applicable (ie FDA. EMA, PMDA etc)
* Work with site Quality and Global QMS Topic leads to define a strategy for QMS development for the Wilmington laboratory.
* Develop approaches to maximize the use of global SOPs at the Wilmington lab.
* When needed map key local processes to support local SOP development.
* Support development of SOPs for Analytical Instrumentation operations and administration.
* Support development of SOPs for Outsourced Testing and Services.
* Ensure appropriate technical, safety and quality review and approval of SOPs takes place prior to deployment.
* Ensure that appropriate change control and training programs are in place for the laboratory QMS.
* Post laboratory start up, support the ongoing maintenance and change control for the laboratory QMS.
* 2+ years of industry experience working directly in the field of analytical test, instrumentation and/or tech transfer.
* Preferably will have a strong Quality background.
* Experience with a number of the following key levers:
* Experience with laboratory instrument Commission and Qualification, Data Integrity and Quality Systems.
* Experience with SOP creation and update.
* Good knowledge of global compliance requirements.
* Demonstrated examples of driving change in a positive way.
* Location; US, Delaware, Wilmington (On site role)
* The successful individual will need to be available on site at the Wilmington Biotech site
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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