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MSAT - Quality Engineer

GSK
Full-time
On-site
Zebulon, NC
Operations

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Role Summary

Join GSK as a Quality Engineer within the Manufacturing Science and Technology (MSAT) team and play a vital role in ensuring the highest standards of quality and compliance in our manufacturing processes. In this role, you will collaborate with cross-functional teams to optimize processes, solve technical challenges, and drive continuous improvement initiatives. We value candidates who are detail-oriented, proactive, and passionate about making a meaningful impact. This is an opportunity to grow your career while supporting GSKβ€šΓ„Γ΄s mission to unite science, technology, and talent to get ahead of disease together.

Responsibilities

  • Collaborate with cross-functional teams to investigate and resolve quality problems by identifying root causes and implementing corrective and preventative actions.
  • Maintain accurate and up-to-date documentation related to Product Lifecycle Management (PLM). Ensure process improvements are sustained through in-use and effective review.
  • Support and coach team members in procedures for managing quality problems (DMAIC, CAPA, Complaints) and make aware of the importance of quality and the issues involved.
  • Apply structured problem-solving methodologies (e.g., 5 Whys, Fishbone, Human Error Evaluation) to support accurate and thorough documentation of root causes.
  • Translate complex technical findings into clear, concise, and structured documentation using approved templates such as the Investigation Root Cause Analysis (DMAIC) and CAPA Template.
  • Ensure consistency and traceability across investigation sections, carrying forward key information (e.g., problem statements, impact assessments) throughout the lifecycle of the report.
  • Identify opportunities to improve product quality, manufacturing processes
  • Participate in audits and inspections by providing documentation support and ensuring readiness of investigation records.

Qualifications

  • Bachelorβ€šΓ„Γ΄s degree in engineering, chemistry, microbiology, or a related field.
  • 3+ years of experience in a regulated manufacturing environment.
  • Experience with validation protocols and risk assessments.
  • Experience with GxP documentation and regulatory compliance.

Preferred Qualifications

  • Advanced degree in a relevant field.
  • Strong knowledge of quality engineering principles and regulatory guidelines.
  • Excellent problem-solving skills and attention to detail.
  • Familiarity with lean manufacturing and continuous improvement methodologies.
  • Previous experience supporting regulatory audits and inspections.
  • Strong organizational skills and ability to manage multiple projects simultaneously.
  • Passion for innovation and driving process improvements.
  • Effective communication and collaboration skills to work across teams.
  • Experience with automated systems and validation software.
  • Knowledge of Human Factors and error-proofing strategies.
  • Ability to work independently and manage multiple priorities under tight deadlines.
  • Analytical and problem-solving skills
  • Familiarity with relevant industry standards and regulations