QC Scientist

GSK • King of Prussia, PA

1d

About The Position

The QC Scientist will be responsible for testing drug product and drug substance samples for release, stability, and in-process, sampling, testing, and releasing raw materials for production use and performing environmental monitoring of the production areas. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Perform and train others on testing of laboratory samples (raw materials, drug product, drug substance, in-process, water, etc) utilizing various microbiological techniques and assays including Environmental Monitoring, Bioburden,and Endotoxin (see Section C for details). Prepare laboratory samples for analysis and prepares laboratory standards and solutions. Perform sampling and laboratory testing of raw materials for quality disposition in support of manufacturing operations, technical transfers, and special studies within the product supply chain. Manage samples and associated documentation for duration of sample lifecycle, both physically and electronically. Author and Participate in laboratory investigations. Author, review, and revise SOP’s and support Electronic Notebook template development (testing electronic lab notebook templates, author user requirement specifications, etc) Reviews and approves laboratory data. Performs routine departmental GMP activities (lab instrument calibrations, preventive maintenance, audits, work orders, etc) Support analytical and instrument lifecycle, technical transfer, and/or validation Laboratory upkeep, maintenance, and continuous improvement (5S, routine equipment/glassware cleaning, etc)

Requirements

• Bachelor’s degree in a scientific discipline
• 2+ years of experience in a laboratory environment

Nice To Haves

• Biopharmaceutical testing experience is preferred, ability to learn various techniques and assays.
• Assays include (but not limited to) – pH, Appearance, Osmolality, Moisture, CGE, ELISA, cIEF, Bioassay, SEC, SPR, Protein Concentration, HPLC/UPLC, PCR, Colorimetric Titrations, FTIR, TOC, Conductivity, Wet Chemistry.
• Microbiological assays include (but not limited to) Bioburden, Endotoxin, Environmental Monitoring, Growth Promotion, Biological Indicators, Disinfectant Efficacy.
• System experience preferred – SAP/ERP, LES, LES-EM, Webstatistica, etc.
• Experience with MS Excel, Word, Powerpoint
• Working knowledge of cGXP, ICH guidelines, FDA, USP/EP/JP and data integrity guidelines and regulations

Responsibilities

• Perform and train others on testing of laboratory samples (raw materials, drug product, drug substance, in-process, water, etc) utilizing various microbiological techniques and assays including Environmental Monitoring, Bioburden,and Endotoxin
• Prepare laboratory samples for analysis and prepares laboratory standards and solutions.
• Perform sampling and laboratory testing of raw materials for quality disposition in support of manufacturing operations, technical transfers, and special studies within the product supply chain.
• Manage samples and associated documentation for duration of sample lifecycle, both physically and electronically.
• Author and Participate in laboratory investigations.
• Author, review, and revise SOP’s and support Electronic Notebook template development (testing electronic lab notebook templates, author user requirement specifications, etc)
• Reviews and approves laboratory data.
• Performs routine departmental GMP activities (lab instrument calibrations, preventive maintenance, audits, work orders, etc)
• Support analytical and instrument lifecycle, technical transfer, and/or validation
• Laboratory upkeep, maintenance, and continuous improvement (5S, routine equipment/glassware cleaning, etc)

Benefits

• Comprehensive benefits program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level