Quality Assurance SME

The Quality Assurance SME leads complex quality investigations, drives continuous improvement, and serves as a key technical resource supporting regulated pharmaceutical and vaccine manufacturing operations. This role owns the full lifecycle of quality records within electronic systems, collaborates closely with cross-functional teams to mitigate process risks, and helps strengthen the overall quality culture through coaching, documentation, and participation in inspections.

• Lead complex deviation investigations from initiation through closure, ensuring thorough root cause analysis and development of effective corrective and preventive actions (CAPAs).
• Own the complete lifecycle of quality records within Veeva, including creating, managing, and closing Change Controls, Impact Assessments, and Effectiveness Checks.
• Represent the Quality function in area huddles and routine meetings, partnering with Engineering, Production, and TSMS to identify, assess, and mitigate process risks.
• Serve as a primary technical resource and subject matter expert during internal, corporate, and regulatory inspections, including those conducted by USDA and FDA.
• Review, revise, and maintain standard operating procedures (SOPs) and training materials to ensure alignment with current processes and regulatory expectations.
• Provide coaching, guidance, and on-the-floor support to operational staff to enhance quality awareness and strengthen the site’s quality culture.
• Apply advanced critical thinking to analyze complex technical issues, interpret data, and recommend robust, compliant solutions.
• Produce clear, accurate, and well-structured technical documentation, including investigation reports and impact assessments.
• Collaborate with laboratory, production, and engineering teams to ensure quality assurance principles are consistently applied across processes.
• Support continuous improvement initiatives, leveraging quality data and lessons learned from investigations to prevent recurrence of issues.

• Proven experience in pharmaceutical processes, vaccine manufacturing, or laboratory Quality Control.
• Strong quality assurance background, including deviation management, CAPA development, and document control.
• Advanced critical thinking skills with the ability to solve complex technical problems in a regulated manufacturing or laboratory environment.
• Strong technical writing skills, particularly for investigations, impact assessments, and other quality documentation.
• Working knowledge of USDA and FDA regulatory expectations in manufacturing settings.
• Foundational understanding of scientific disciplines such as Biology, Chemistry, Microbiology, Animal Science, Food Science, or Biochemistry.
• Ability to collaborate effectively with cross-functional teams including Engineering, Production, TSMS, and laboratory staff.
• Demonstrated ability to represent Quality during audits and inspections, providing clear, confident responses to technical and compliance questions.

• Bachelor’s degree in a science-related field such as Biology, Chemistry, Microbiology, Animal Science, Food Science, or Biochemistry, OR an Associate’s degree with relevant industry experience.
• Hands‑on experience with Veeva quality systems.
• Experience with SAP or similar enterprise resource planning systems.
• Prior experience working in a USDA or FDA regulated manufacturing environment.
• Knowledge of Lean and Six Sigma methodologies and their application to process improvement and defect reduction.
• Experience with CAPA management, change control processes, and effectiveness checks in a regulated setting.
• background in laboratory operations, vaccines, and quality control…