Roche
Pharmaceutical
QCPartner
Neural analysis suggests this role is
optimal for Mid candidates.
“QC Partner at Roche. Skills: QC Testing, Method Transfer, Investigation. Perform QC testing. Manage QC materials”
Industry & Context.
Risk assessments; Root cause analysis
What They're Looking For.
Must Have
Bachelor of Science majoring in biotechnology or related science, A minimum of 4 years experience in developing and executing quality control operation, and laboratory experience in pharmaceutical company, A background and in-depth knowledge in Instrumental analysis (HPLC, UV, CE, Spectrophotometer, Plate Reader, etc. ) and cell-based assays, Good English written and communication skill
What You'll Do.
Perform QC testing, Manage QC materials, Lead method transfer, Handle deviations, Act as auditor, Conduct data review, Execute equipment management, Draft QC SOPs
How You'll Work.
Team & Collaboration
Collaborate with RA
Communication Scope
Good English written and communication skill
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position **Affiliate: Roche Pharma Korea** **Cluster: Access & Policy** **Work Location: Hanam City, Gyeonggi-do** **Worker Type: Regular** **Your key responsibilities** * **Advanced QC Testing:** Perform QC testing for biological/chemical drug products utilizing various compendial and in-house validated methods (e.g., ID/Purity by CE, HPLC & UPLC, Content by UV/Vis, Cell-based Assays), ensuring strict adherence to SOPs and test protocols. * **QC Material & Cell Bank Management:** Manage and maintain critical QC materials including QC/retention samples, critical reagents, and cell banking. * **Method Transfer (SME):** Lead or support internal/external analytical method transfer activities, providing technical expertise on key analytical methods as a Subject Matter Expert. * **Investigation & Quality Management:** Handling of deviations, OOS/OOT investigations, change controls, CAPA, and risk assessments, identifying root causes and implementing effective actions. * **Audit & QMR Leadership:** Act as an internal or external GxP auditor/co-auditor and represent the QC function as a member of the local QMR (Quality Management Review) Meeting. * **Data Integrity & Review:** Conduct technical review of QC raw data and analytical results, adhering strictly to the current GxP good documentation practices and data integrity requirements. * **Equipment Lifecycle Management:** Execute and coordinate qualification, calibration, and preventive maintenance of QC equipment ensuring intended use. * **Documentation &
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