To lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions.Evaluate audit findings and prepare and distribute responses to operations staff and management.Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.Provide consultation to staff in interpretation of audit observationsManage Quality Issues and serious breach investigations.Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans. Track until closure quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.Present educational programs and provide guidance to operational staff on compliance procedures.Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.Assist in training of new Quality Assurance staff.Support in QA initiatives/projects for quality, process improvements.Manage/oversee quality events updates in eQMS.Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.

- Plan, schedule, conduct, report, and close assigned audit activities in any of the countries involved with Q Squared Solutions contracts to assess compliance with applicable regulations/guidelines, customer requirements, Q Squared Solutions SOPs and project specific guidelines/instructions.- Conduct quality assurance activities and projects for clients according to Q Squared Solutions departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits.- Assist in preparation and review of corrective action plans.- Represent quality assurance program on customer and project teams under the direction of more senior QA staff.- Document and report quality and compliance issues to QA management according to required timelines.- Advise quality assurance management on system audit needs.- Assist in hosting customer audits, mock regulatory inspections, and facility inspections by serving as Scribe, customer audits independently as directed by QA line management.- Assist in preparation and review of corrective action plans associated with customer audits.- Enhance and maintain a working knowledge of relevant GXP regulations.

Conduct investigation and write reports in response to company PTCsAssist production with in-house investigationsSupport other departments with Materials Clearance testing and other methodsOperate FTIR, Stereomicroscope, and RAMANParticle Isolation and AnalysisIncident Investigations (Trackwise)Visual Indentification and Analysis of Stability samplesSDS PAGE gelWestern Blot

Promote safety and quality in all aspects of processingOversee daily processing activities to ensure samples are processed efficiently and effectively according to SOP'sMonitor processing to ensure the department maintains compliance and oversee daily activities of 7 employeesResponsibilities include daily troubleshooting, problem solving, and effective communicationEnsure documentation meets GMP guidelines to maintain sample integrity and complianceCrossed trained on NAT testing procedures and paperwork verificationTrained in SAP Basic and Ordering from the WarehouseProficient in Trackwise (Incident Investigation System)

Execute biological testing in all classified areas within manufacturing in a effective and efficient manner while following pertinent SOPsDirect validation projects of new rooms within manufacturingLead role during multiple shutdownsGown certified for all GMP classified areasBEST and BEIT trainedMaintained a monitoring schedule to support productionRead and recorded the results of tested rodac plates, settling plates, and RCS strips in an efficient and accurate mannerTrained to operate LIMSAuthor trained for writing and revising SOPsTrained on new tests and procedures such as calibration of equipment, plating media, KTA, etc.