Quality Control Scientist
Glaxosmithkline
Position Summary You will perform and review laboratory testing to ensure products meet quality and regulatory standards. You will work closely with manufacturing, quality assurance, and engineering teams, investigate unexpected results, and support corrective actions. This role offers clear paths to grow technical and leadership skills while helping GSK unite science, technology and talent to get ahead of disease together. Responsibilities Be SME for Microbiology tests/processes. Evaluate micro tests/processes, optimize to incorporate GSK best practices, incorporate efficiency, and address regulatory gaps. Serve as SME during internal and external audits. Conduct microbiological testing and environmental monitoring and train colleagues on these assays. Have a continuous improvement mindset, engaged in the production system methodologies, and demonstrating excellence by improving procedures/methods/logbooks, ways of working, and housekeeping to maintain compliance and eliminate waste. Record, review, and approve laboratory data with attention to accuracy and data integrity. Lead or support investigations into atypical, out-of-specification, or deviation events and recommend corrective actions. Maintain laboratory equipment, calibration records, and support method validation or transfers. Contribute to SOPs, electronic lab notebook templates, and continuous improvement projects. Provide accurate results and interpret data in compliance with cGMP’s, procedures and all applicable regulations. Follow up on questionable results and notify QC Microbiology Supervisor in a timely manner. Perform environmental monitoring sampling in Building 40, as needed. Testing may occur on first and second shifts and may include weekend and/or holiday work. Ensure all equipment, supplies and reagents are available and in a GMP state to support testing that is right-first time and on time. Execute reagent, standard qualifications as required. Perform data review/logbooks reviews in a timely manner; manage to ensure releases meet SLA timelines. Serve as project manager for Microbiology/QC projects. Work to identify tasks, schedules, and budget for project, and execute plan. Provide routine updates on project status. Conduct analyst qualification/training of the team. Execute validation protocols and reports and other equipment-related documents. Basic Qualifications Bachelor’s degree in a scientific discipline such as chemistry, biology, biochemistry, or equivalent practical laboratory experience. 2+ years of experience with a regulated laboratory environment with at least one year within quality control for microbiology, chemistry or biochemistry fields. Experience performing routine analytical or microbiological testing and following laboratory procedures. Experience documenting results and maintaining records in line with data integrity expectations. Preferred Qualifications MS or PhD in Biology or Microbiology. Strong written and verbal communication skills and ability to work effectively within cross-functional teams. Experience with analytical techniques such as HPLC/UPLC, PCR, ELISA, or relevant wet chemistry methods. Experience with microbiological assays including bioburden, endotoxin, or environmental monitoring. Experience with laboratory systems such as LIMS, LES, or SAP for sample and data management. Experience conducting investigations, root cause analysis, and implementing CAPA. Experience supporting method validation, instrument qualification, or technical transfer activities. Demonstrated focus on continuous improvement and previous participation in process improvement projects. Work Arrangement This role is on-site. The specific working model will be confirmed during hiring. Equal Opportunity Employment 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. 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 View email address on click.appcast.io. #J-18808-Ljbffr
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