Current Openings

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- Philadelphia, PA

The QC Compliance Lead will be directly responsible for GMP compliance in quality control laboratory. Under the general guidance of the management, s/he will work independently to ensure all data integrity and GMP/GDP and regulatory requirements are met. - Develops and oversees systems and authors SOPs to manage the department metrics. - The QC Compliance Lead will hire, train and manage a small team of QC Compliance associates to meet the business needs - Responsible for developing and....

- Philadelphia, PA

The Sr Quality Control System Specialist will serve as the administrator for all QC laboratory computerized system/s. S/he will be the point contact person in the Quality Control and Analytical Sciences department for any system related issues. The Sr Quality Control Systems Specialist will be responsible for the selection, implementation and on-going oversight of the QC LIMS system, as well as other future electronic laboratory system initiatives (e.g. Laboratory Execution System.) S/he will....


The Environmental, Health & Safety (EHS) Lead will be responsible for developing, implementing and managing Spark’s EHS program. S/he will be responsible for monitoring site activities and ensuring compliance with federal, state and local regulatory requirements at all Spark sites and locations globally (current and future sites). This individual will ensure EHS compliance across multiple functions, and will work closely with R&D, Finance/Procurement, Quality Assurance, Project....


As part of an overall cross functional Software Development Lifecycle (SDLC) approach to computer systems compliance and validation, the Sr Computer Systems Validation (CSV) Specialist will be involved in all aspects of computer systems validation and qualification within a GxP regulated environment. Under the general guidance of the Computer Systems Validation Lead, the Sr CSV Specialist will be involved in the overall development and maintenance of GxP system lifecycle documentation. This....


The primary goals of Analytical Sciences are: to lead the phase-appropriate optimization, qualification, verification and validation of analytical methods across the product development lifecycle from clinical to commercialization; provide support to QC in the investigation of non-conformances, invalid assays; and troubleshooting method problems. Analytical sciences will also be responsible for developing and overseeing a critical reagents management program, the reference standard program,....

- Philadelphia, PA

Under the general direction of the Drug Product Manufacturing and Facilities Lead, the Logistics and Supply Chain Lead will work across clinical and commercial products to ensure reliable, accurate, and consistent supply coordination and movement plans. S/he is responsible to build an efficient supply chain function to support the commercialization of SPK-RPE65. He/She will support the launch team with all supply chain related activities (lead time, batch size, supply scenarios, inventory, and

1-6 of 6 results