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)
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in a scientific discipline
2+ years of experience in a GMP/GxP regulated laboratory environment
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
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
Role requires weekend and off-shift coverage
#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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