This position is necessary for the biological reference standard and critical reagent inventory management, including qualification, retest extension, warehousing, and distribution.
Accomplish corporate, operational and departmental goals while maintaining GMP compliance.
Perform commercial analytical controls and reference standard stability program activities with guidance, including authoring stability protocols, coordinating testing, analyzing test results, consulting assay SMEs on unexpected results and assisting in QC investigations as needed, and completing stability reports and necessary changes to controlled documents owned by Global QC.
Provide Labware LIMS support as required, including master data testing for commercial analytical controls and reference standard management in LIMS
Perform commercial reference standard and critical reagent inventory management with guidance, including warehousing, distribution and replenishment as required.
Complete training or provide cross-training as required on business processes and procedures.
Perform tasks as requested by Management to support department goals.
Identify and participate in continuous improvement initiatives that may impact the department performance.
Perform compliance review for QC documents as required. Sign documents for activities as authorized and described by Roche policies, procedures and job description.
Accountable for behaviors described in Roche's Core Values.
Adhere to cGMP compliance and complete training on time.
B.S. or M.S. in Chemistry, Biochemistry or equivalent with at least 2+ years of experience in a pharmaceutical or related industry.
Strong knowledge of cGMP, regulatory requirements and analytical control strategy for pharmaceuticals.
Prior experience in analytical technologies and data analysis using statistical software is preferred.
Excellent verbal and written communication skills.
Technical writing skills are required.
Flexibility in problem solving and work hours with minimum guidance from management to meet business objectives.