Sr Quality Assurance Engineer

We’re looking for a Senior Quality Assurance Engineer to support aseptic manufacturing operations in a highly regulated environment. This role plays a key part in ensuring product quality, regulatory compliance, and operational excellence across manufacturing and validation activities.If you enjoy solving complex quality challenges, working cross-functionally, and making a meaningful impact in a GMP environment, this could be a great fit.What You’ll Be DoingProvide QA oversight for aseptic fill/finish manufacturing activitiesPartner with manufacturing, engineering, QC, and supply chain teams to investigate issues and implement corrective actionsLead and support quality investigations, including root cause analysis and data reviewReview and approve qualification and validation protocols/reports (equipment, utilities, processes, systems)Analyze validation data to ensure compliance with established criteriaSupport and approve change controls and represent QA in cross-functional meetingsDevelop and maintain SOPs and quality system documentationConduct risk assessments and help implement mitigation strategiesEnsure compliance with cGMP and regulatory requirementsSupport audits, inspections, and regulatory submissionsPromote a strong culture of quality and safetyWhat You BringBS/BA in a scientific discipline7+ years of experience in pharmaceutical, biotech, or GMP-regulated environments3+ years in QA and validation/qualificationHands-on experience with aseptic fill/finish manufacturing (required)Strong knowledge of GMP, GxP, and validation practicesExperience with investigations, CAPAs, and change controlSolid understanding of risk management and statistical analysis (DOE, SPC, etc. is a plus)Ability to work cross-functionally and influence teamsStrong communication and problem-solving skillsAdditional DetailsAbility to work in a fast-paced, collaborative environmentComfortable working around regulated materials with proper safety protocolsSome schedule flexibility may be requiredAbility to lift up to 50 lbs occasionallyTravel up to 10%