Quality Assurance Specialist

Quality Assurance ManagerIn this role you will strengthen the site's quality oversight by improving the quality system and regulatory compliance across QA, QC, Manufacturing, and Technical Operations. You will analyze data to drive collaborative improvements to processes and systems, manage quality events and document revisions, and maintain qualification across GMP-related duties. You'll partner with cross-functional teams to implement corrective actions and risk-based changes that enhance efficiency while preserving cGMP compliance. This position offers impact in quality governance and site-wide quality performance.Compensation / Benefitscompetitive payannual performance bonusmedical/dental/vision coverage401(k) plan with employer contributionpaid vacationpersonal and sick daysResponsibilitiesEvaluate global and local regulatory requirements to identify improvement opportunities and draft SOPs and work instructionsCollaborate with Operations to drive sustainable corrective actions from quality eventsCoach and assist teams to complete timely corrective actionsDevelop and communicate Quality Event Metrics and KPIs (Deviations, Change Management, CAPAs, Risk Management, OOS)Develop and deliver focused cGMP training for Operations personnelIdentify coaching needs for Operations on cGMP compliance and Quality EventsLead risk management initiatives to drive proactive risk reductionIdentify workflow inefficiencies in QA and other Operations departments and implement risk-based improvementsMaintain qualification for roles supporting the Quality System (document review/approval, deviation investigations, CAPA, Change Management, Risk Management, OOS)Support audits, site visits, and inspections as requiredKey requirementsBachelor's Degree in Biological Sciences, Chemistry, or Engineering preferred; 8+ years in a cGMP environment; 5+ years in Quality Assurance; experience in pharmaceutical/biopharmaceutical or medical device industries preferredStrong knowledge of cGMP investigations, including deviations, OOS, and environmental excursionsProficient in root cause analysis tools (Fishbone, 5 Whys, Is/Is-Not)Strong technical writing for reports, investigations, impact assessments, and SOPsProactive, self-starting attitude and ability to seek guidance when neededProficient in CAPA and measuring effectivenessProficient with Change Management governance and workflowsCollaborative with stakeholder departments and skilled in conflict resolutionExperience with data entry, analysis, and presentation for Quality Metrics and KPIsExperience with QMS systems such as MasterControl, Trackwise, VeevaCollaboration, conflict resolution, proactive communication, cGMP investigations, CAPA management, Change Management American Statistical Association - ASA