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Job Description
Please note that this is a 'internal job posting' link, intended for GSK/ViiV employees only. Contingent Workers should check with the recruiter of the Job Requisition to confirm whether the job is open to contingent workers and to obtain the correct job posting hyperlink. Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines. 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 c
GXP, ICH
guidelines, FDA, USP/EP/JP and data integrity guidelines and regulations Role requires weekend and off-shift coverage #LI-GSK If you require an accommodation or other assistance to apply for a job at GSK/ViiV Healthcare, please submit a request to HR via the Service Portal 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. This Position Description is to provide a framework for job understanding between employee and manager. It may not cover or contain the full listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice and at the discretion of the management of the Company. The position description is not used in the assignment or assessment of any GSK level or grade used in the Job Evaluation Process.