Primary duties of the position are focused on non-laboratory support of the QC functions.
Primary activities would generally include but not limited to analytical method transfer, analytical method validation, data analysis, data trending, project and testing coordination product and material specification management, inspection support, document authoring, revisions, initiating/completing quality systems, method/equipment validation and method projects activities.
Area is focused on data analysis, data trending, project and testing coordination product specification management, LIMS interface, CoA generation, (including interaction with the IT systems such as LIMS that enables electronic management of this activity), and inspection support.
Data analysis and trending of stability data, data reporting, coordination and planning of stability studies, involvement on quality events requiring stability input.
Various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities, method monitoring), critical reagents and reference standard programs.
Various projects in support of the Raw Materials department. Support includes (but not limited to) material specification creation/revision, document creation/revisions, initiating/completing quality systems, method/equipment validation and implementing operational excellence initiatives.
Experience in Analytical Method Transfer, Analytical Method Validation, HPLC, Bioassays, CE assays, compendial verification, biologics.
Requires a bachelor’s degree and a minimum of 5 years of related experience.
Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask.
Conducts work in compliance with cGMPs, safety and regulatory requirements.
MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
Seniority level
Associate
Employment type
Full-time
Job function
Finance and Sales
Industries
IT Services and IT Consulting
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