STABILITY SCIENTIST(Job Number: 1300649)
Support activities of the Syracuse Quality Control Stability program which includes management of studies to support site manufacturing; as well as, stability programs for other sites and Third Party Manufacturers (TPM). Responsibilities include:
•Support program administration by maintaining a schedule of pull dates required testing, preparing for or providing oversight for sample pulls as required by schedule.
•Communicate directly with management information regarding stability samples or testing that may impact lab capacity or product studies.
•Monitor specification changes and ensure appropriate specifications and method changes are updated for studies.
•Draft study protocols and manage study programs as requested.
•Provide data for routine trending analyses and update site SOPs as required.
•Serve as a qualified trainer.
•Support daily activities of stability/reserve sample storage facility, this includes: oOversight and back up support of activities related to sample receipt, storage, pulls, shipping and inventory control. oReceipt and processing of reserve sample storage and paperwork. oProvide back up support and monitoring of storage chamber activities and sample destruction in accordance with procedures. oMaintain inspection readiness for facility at all times.
BS degree in a scientific area with a minimum of 5 years experience or a MS degree with 1 to 2 years experience. Knowledge and understanding of ICH guidelines (Q1A, Q5C) and associated guidance and directives. Problem solving ability, interpersonal, oral and written communication skills; as well as, technical writing skills. Able to prioritize objectives from multiple projects, adhering to scheduled timelines. Works independently and contributes to a team based environment; promoting a high commitment to business goals and objectives.
Job Function: Quality
Primary Location: NA-US-NY-Syracuse
: Tech Op - Biologics Syracuse
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