OneSource Account Quality Specialist

ResponsibilitiesLocation Richmond, Virginia US Job ID REQ-057484QMS Oversight & ComplianceEnsure effective implementation and adherence to the QMS and Quality AgreementMonitor compliance, identify risks, and drive resolution of gapsPartner with customer quality to maintain and update the Quality AgreementQuality Leadership & CoordinationAct as the primary on-site quality SME and escalation pointLead and coordinate quality activities across the account teamPromote a strong quality culture and influence without direct authorityAuditing & Inspection Readiness (Proactive Focus)Plan and conduct internal, supplier, and process auditsSupport customer, self-inspections, and regulatory inspectionsTrack audit findings, non-conformances, and CAPA effectivenessDeviation, CAPA & Change Control (Reactive Support)Oversee and support investigations, root cause analysis, and CAPAEnsure timely closure of quality events with minimal operational impactReview and approve quality records in line with delegated authorityTraining & Quality AwarenessOwn the site quality training program with site leadershipDeliver GMP and QMS training and ensure compliance and effectivenessDrive awareness and accountability for quality across all site employeesSupplier Quality OversightSupport supplier qualification, audits, and performance monitoringEnsure supplier compliance with QMS and Quality AgreementAddress supplier-related quality issues with stakeholdersContinuous ImprovementSupport delivery of the site quality plan and improvement initiativesAnalyze quality trends and drive actions to enhance performanceReport on quality metrics and audit outcomes to stakeholdersBasic QualificationsBachelor's degree in a relevant field or equivalent professional experience with a minimum 3 years' experience in quality assurance within a GxP/pharmaceutical environmentDemonstrated experience with QMS processes (deviations, CAPA, change control, audits)Strong knowledge of GMP and regulatory expectationsMust communicate fluently in English.Ability to lead and influence without direct authorityStrong analytical, problem-solving, and decision-making skillsExcellent communication and stakeholder management skillsPreferred CharacteristicsStrong working knowledge of Quality Management Systems in GxP environmentsProficiency in auditing (internal, supplier, and external inspection readiness)Solid understanding of GMP regulations and Good Documentation PracticesAbility to balance proactive and reactive quality priorities in a dynamic environmentProficiency in SAP, ServiceMax, SharePoint, Microsoft Excel, Word, and PowerPoint.Certified Quality Auditor (CQA) or equivalent certificationExperience with Lean / Six Sigma methodologiesExperience working in customer-embedded or outsourced service environmentsWorking EnvironmentMust be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.).Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.The annualcompensation range for this full-time position is $80,000 to $90,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.VEVRAA Federal Contractor.We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.PDN-a1e267e9-d975-49b7-b805-7e362aa2de35