Title: Associate Packaging Engineer
Location: Foster City, CA
Duration: 3-6 months
Assists in the completion of routine technical and operational activities for an assigned group of clinical trials for a compound/indication or equivalent through maintenance of internal and external resources.
Works on routine processes across functions, interacts effectively with the clinical protocol teams such as (biostatistics and clinicians, materials management, quality assurance, formulation/process development, and regulatory affairs groups to provide input into the packaging and labeling configuration/labeling options.
Assists in routine work activities on multiple projects related to the labeling and distribution of clinical supplies to ensure clinical supply study start dates are met.
Assists in the coordinating of packaging and labeling activities onsite and contractor sites, including label artwork design, obtaining approval of label text, approve blinded codes and write and approve batch records.
Works on assignments that are routine in nature requiring a degree of independent action.
Performs PPS, IQS, RCVS, EQMS and EBS (computerized software) transactions and prepares purchase orders for specific programs.
Assists in the equipment/process qualification (IQ/OQ/PQ) and shipping studies and in writing qualification/technical reports.
Performs qualification/characterization of packaging components such as, labels, cartons, bottles, and caps Interacts with external vendors on issues such as procurement of packaging and labeling components, scheduling and performing operations, and generating/reviewing documentation.
With guidance may lead one specific component of departmental strategic initiatives.
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