Quality Control Scientist

GSK•Marietta, PA

2d•Onsite

About The Position

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. 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. You will investigate unexpected results and support corrective actions. We value curiosity, clear communication, and a focus on continuous improvement. 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.

Requirements

Bachelor’s degree in a scientific discipline such as chemistry, biology, biochemistry, or equivalent practical laboratory experience.
2 + plus 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.

Nice To Haves

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.

Responsibilities

Perform routine and stability testing of raw materials, in-process samples, and finished product using approved procedures.
Conduct microbiological testing and environmental monitoring and train colleagues on these assays.
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.
Be SME for Microbiology tests/processes.
Evaluate micro tests/processes, and optimize to incorporate GSK best practices, incorporate efficiency, and address regulatory gaps.
Serve as SME during internal and external audits.
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; 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 to plan.
Provide routine updates on project status.
Conduct analyst qualification/training of team.
Participate in investigations and planned remedial actions for atypical events and/or results in order to support the timely resolution of investigations.
Author associated documentation.
Write, update, and review Laboratory Standard Operating Procedures, Analytical Methods, Specifications and other GMP documents.
Execute validation protocols and reports and other equipment-related documents.