Teva Quality Control Analyst III Day Shift - shift 7am -330 pm 8-430pm 

United States, South Carolina 

401205398

Essential Job Responsibilities

• Provide Analytical technical service support to QC
• SME TrackWise change controls for specifications/method revisions in wisdom/LIMS
• SME Wisdom Teva doc for revising, creating, reviewing and making effective specifications and method documents.
• SME LabWare LIMS PROD_SPEC role for creating and revising specifications in LIMS and resolve LIMS specification issues
• Support alternate supplier project and perform method transfer for required methods such as Impurity and residual solvent
• Additional responsibility for Compendial Compliance to track USP/NF update for monograph, general chapters etc., track assessment in compendia review TW change controls, Initiate change control if any specification/method revision required
• Additional responsibility for packaging engineering specifications for Labels, Outserts, Shippers, Bottles, Closures which need creation or revision due to either regulatory change or supplier change notification.
• Method remediation, validation studies testing, initiate protocols, set up HPLC, process and report data and draft reports.
• Revise packaging component printed labels/outserts specification in Wisdom/LIMS
• Creating protocols to perform USP verification testing and issuing verification reports prior to USP monograph becoming effective
• Revise residual solvent reports based on USP or supplier notifications
• Creating TrackWise CAPA’s for method/specification assessment, corporate standard gap analysis related to method transfer/ method validation
• Support QC chromatography tests and chromatography data review and additional QC projects as per business need
• Assigned project such as corporate standard gap assessment, SOP revision, CAPA, Lab Investigations etc.
• Train QC Analysts when required

Required:

• Good computer skills including MS Office, protocol/report writing
• Working knowledge and experience using Labware LIMS documentation system, Trackwise for change controls, laboratory investigations and CAPA
• Knowledge of method validation/ method transfer
• Working knowledge of USP/PF updates, tracking changes, implement and update method/specification
• Working knowledge of HPLC, GC and other spectroscopic methods (UV/Vis spectrophotometer, FTIR, Raman spectroscopy), dissolution and other stand-alone systems
• Strong analytical skill to troubleshoot HPLC/GC instruments and Empower data acquisition system
• Knowledge to perform method transfer/remediation projects, analysis of raw material and finished dosage pharmaceutical products
• Good at multitasking, handling multiple projects at one time, and changing priorities based on business needs
• Working knowledge of USP, and cGMP, requirements in a pharmaceutical quality control laboratory
• Must be detail oriented, self-driven, and motivated
• Good organization skills and attention to detail
• Strong interpersonal, oral, and written communication skills
• Able to work effectively independently and as part of a team
• Knowledge of ERP system SAP
• Knowledge on Laboratory safety procedures

Education Requirements:

• Bachelor’s/master’s degree in chemistry or related science
• Minimum ten (10) years of Analytical laboratory experience

Physical Requirements:

• Not allergic to chemicals or bio substances found in laboratory or production facilities.
• Not Allergic to Penicillin/Cephalosporin drug products
• May be required to lift/move up to 50lbs.
• Individual may be required to handle hazardous and non-hazardous materials.
• Individual may be required at times to wear Personal Protection Equipment.
• May be required to lift/move up to 50lbs.
• Individual may be required to handle hazardous and non-hazardous materials. Individual may be required at times to wear Personal Protection Equipment.
• Not allergic to chemicals or bio substances found in laboratory or production facilities.

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