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Essential Duties - Pharmacy/Log-In
∑ Assist with picking up and maintaining custody of all incoming materials from clients from Shipping/Receiving.
∑ Generate tracking forms and study related documents (Sponsor communications, protocols, requisition form) for all relevant studies.
∑ Properly store and track all materials (including dosing formulations and other study related materials) maintained in the Pharmacy.
∑ Track removal and return of all test materials.
∑ Reconcile and account for all materials appropriately at the end of a study as directed by the Sponsor or Study Director.
∑ Maintain up to date accurate records for materials that have entered the pharmacy and records of use and log out of materials for both formulations, dosing and other usage.
∑ Work with Study Directors to accurately determine if additional materials are needed.
∑ Work with Health and Safety for proper storage, formulation and use of any potentially hazardous materials.
Essential Duties - Formulations
∑ Responsible for preparation and processing of formulations per instructions in protocols and/or SOPs.
∑ Generate and maintain records on all dispensation, preparation, routing and custody of samples.
∑ Maintain active inventory of test article, control articles, vehicles, carriers, etc.
∑ Assist in the characterization and verification procedures of formulations with the Analytical Chemistry department.
∑ Maintain Formulations Laboratory and instruments per Equipment Usage procedures and interface with Metrology and Validation services as required.
∑ Maintain all equipment records and submit monthly performance verification records for the Formulations Laboratory.
∑ Maintain all required records to quality standards and completeness requirements.
∑ Assist in managing technical and regulatory site visits to the laboratory and interface with QA and RA on all vendor/regulatory audits.
Essential Duties - Study Support
∑ Maintain and monitor schedule of performance, flow of information and reporting of studies. Ensure that reports are reported timely and all special testing preparations are properly handled
∑ Participate in the daily scheduling, forecasting and needs of the Formulation Laboratory.
∑ Assist project management and other sales staff with quotation/pricing information.
∑ Maintain laboratory accreditation and registrations as required.
∑ Interact with clients as required.
∑ Bachelorís Degree in chemistry or pharmaceutical sciences.
∑ Experience in the preparation, processing and testing of dose formulations (sterile or non-sterile) for pre-clinical pharmaceutical studies.
∑ Must have strong organizational skills and ability to multi-task in a fast paced environment.
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