Ronkonkoma, New York, United States
Quality leader with over 20 years experience in both Quality Control and Quality Assurance that plays a crucial role in ensuring the company's products meet regulatory standards and quality expectations. This includes overseeing the development, implementation, and maintenance of quality management systems (QMS) is in regulatory compliance. A trainer and mentor to staff to promote a culture of compliance and continuous improvement.
Manage the Quality department for an AS9100 aerospace & defense organization •Direct daily operations of the quality department, establishing priorities, developing standards and setting the workflow. •Develop and optimize all aspects of the Quality Management System aligned with AS9100, including but not limited to internal audits, supplier management, NCRs, CAPAs, customer feedback processes, Management Review, and document control. •Represent the company to customers, auditors, and regulatory authorities on all Quality matters. •Participate in NPI design & development reviews. •Establish, monitor, and report on key quality metrics and use the data to drive decisions and continuous improvement.
-Drive agenda planning and follow-up actions for leadership meetings, global quality teams. -Monitor and report on project status, risks, and outcomes for ongoing quality initiatives. -Developed new corporate Quality Management System. -Track Quality KPIs and quality performance. -Serve as liaison between the Global Quality leader and internal/external stakeholders. -Prepare executive-level presentations, briefing documents, and communications. -Coordinate cross-regional and cross-functional collaboration on quality programs, including regulatory readiness, audit outcomes, and continuous improvement. -Support talent development initiatives, engagement programs, and leadership effectiveness within the quality organization. -Foster a culture of accountability, Quality excellence, and compliance.
Full QMS Management - for a FDA and DEA regulated facility. *Lead product planning and realization projects from beginning to end. * Spearhead MRB meetings * Review and revise all Quality Documentation, including batch records, production records and shipping documents. *Perform QA Receiving, In-process and Final inspections. Final DHR review and signature for Certificates of Analysis of finished goods. *Maintain and update Regulatory documentation as required. *Provide company-wide GDP/GMP trainings. Manage the Training program company-wide. *Lead MRB & investigations for CAPA, Non-Conformances, and Customer Complaints. *Experienced in internal and external audits. The QA representative present for all Regulatory inspections. Write up Audit responses and follow through to closure. *A project leader for the ISO13485:2016 upgrade certification, Label Barcode/UDI implementation for FDA compliance and lead/author of EU IVDR technical documentation. *Site PRRC.
• Assign, track and independently manage CAPAs using Trackwise. • Compile weekly & monthly QA reports. • Create monthly KPI Powerpoint reports for the Global QA Department. • Contribute as SME with Product Impact Assessments & Investigations.
• Raw material, in-process and final product Bioburden & Endotoxin testing • Environmental Monitoring: Surfaces, Viable Air and Total Particulate Testing • LAL Endotoxin testing, Validation of the Endotoxin test via Inhibition & Enhancement Testing by Gel-clot method • Qualification of Biological Indicators & Endotoxin Indicators • Perform non-routine testing such as Method Transfers & Technical Studies and write the associated Technical reports & SOPs. • Sterility testing • Environmental Monitoring • Train new employees on Bioburden and Endotoxin testing • Compile Quarterly & Annual Reports • Perform & write up Laboratory investigations & address any CAPAs • Revise and/or write new Standard Operating Procedures in accordance with current USP methods.
• Responsible for the training and supervision of employees • Animal Husbandry • Weaning & genotyping of F1 generation mice • Clip tail samples & perform genotyping • Perform PCR & DNA extraction technques • Dissections of mice uteri for collection of blastocysts • Facilitate animal shipments to proper research institutions.