QC Scientist

GSK•King of Prussia, PA

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) Why you? 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [email protected] GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Requirements

Bachelor’s degree in a scientific discipline
2+ years of experience in a GMP/GxP regulated laboratory environment

Nice To Haves

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 (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)