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QC Supervisor/Manager, Raw Materials

Company: Evorec Group
Location: Redmond
Posted on: July 30, 2022

Job Description:

Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The candidate will provide leadership in a fast paced, collaborative QC group. The candidate will oversee and participate in the sampling and external testing of incoming raw materials prior to their use in cGMP manufacturing. The candidate will work collaboratively with other teams to ensure that raw materials are released prior to their need by dates in compliant manner. The successful candidate will have extensive cGMP compliance experience, exceptional attention to detail and have experience designing and implementing efficiency improvements. Responsibilities:Lead a QC raw materials testing program to support commercial manufacturingOversee the inspection, sampling, and external testing of incoming raw materials prior to use in manufacturing, according to US and EU GMP requirementsEnsure materials are sampled in accordance to SOPs, entered into the data management systems, and are available for use on timeParticipate in the qualification of raw materials via external testingLead the implementation of a Raman based ID testing programServe as subject matter expert in review of raw material specificationsParticipate in vendor audits as a technical advisorOversee the daily routine activities of the raw materials group, provide data review and ensure the operation remains compliant at all timesCollaborate with Quality Assurance, Manufacturing, Material Management, external vendors, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved. Provide expertise for the IOPQ of Raman instrumentation for raw material ID testing, including troubleshooting and routine equipment maintenanceAuthor and maintain required cGMP documentation such as SOPs and guidance documentsOversee verification of assays at external testing labsIdentify gaps, design collaborative solutions, and implement improvementsParticipate in external testing labs QC laboratory investigations, deviations, OOS, and CAPAsRequirements:BS in Biochemistry, Chemistry, or related field with > 5-8 years cGMP experience with raw materialsExtensive experience with raw material sampling, including handling of powder and liquids, using aseptic techniquesKnowledge of cGMP raw materials tests including pH, conductivity, osmolality, moisture, appearance, HPLC, etc.Knowledge of verification and validation of assays required for raw material testingExperience with Raman for IDExtensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) Extensive knowledge of GDPs, GMPs multi-compendial assays (USP, EP, JP) Excellent communication and collaboration skillsAttention to detail, highly organized, able to meet schedules and timelines and handle multiple prioritiesMiddle Management

Keywords: Evorec Group, Redmond , QC Supervisor/Manager, Raw Materials, Executive , Redmond, Washington

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