Jonathan Fetter Email & Phone Number

Elverson, Pa, Us

Elverson, Pa, Us

Craigavon, County Armagh, Gb

QA oversight of quality systems and packaging batch record processes.• Perform QA review and approval of deviation and complaint investigations, change controls, CAPAs, vendor queries, SOPs, specifications, and other controlled documentation. • Lead teams performing master batch record generation and executed batch record review and batch release.• Drive timely closure of quality records, and monthly KPI collection/reporting.• Communication with customers concerning quality-impacting events.• Perform internal audits.• Led the back room during 2017 regulatory inspection.

Tokyo, Jp, Jp

QA oversight of global Supplier Quality and BSE/TSE and Allergen documentation. • Maintain Quality Agreements and Audit documents to ensure supplier qualification and accurate Approved Supplier List. • Author declarations of product TSE and allergen content. Integration of TSE/Allergen and National Drug Code (NDC) systems and external suppliers from company acquisitions.• Provide timely responses to Medical Affairs patient inquiries concerning Shire products.• Member of Shire-Baxalta Supplier Quality Management integration team.

Tokyo, Jp, Jp

QA oversight and process ownership of global Annual Product Quality Review (APQR) systems. • Led a four-member team dedicated to performing APQRs for small molecule, biologic, and combination products. • Led cross-functional APQR review meetings; performed review and approval of APQRs. • Authored deviations and CAPA related to the APQR system. • Authored corporate quality standards/quality manual for APQR system.

Tokyo, Jp, Jp

Quality oversight for all company products, as part of the Product Quality Management team. • Led ad-hoc cross-functional quality incident escalation meetings to identify next steps.• Leader of Global Product Council (GPC), a monthly meeting providing visibility cross-functionally to the assessment of process capability and control, driving continuous improvement, and escalating issues to senior leadership.• Conducted annual recall (mock) simulations. • Provided weekly updates to executive management and stakeholders of open incidents. • Continued support of APQR system, providing management review and approval of APQRs.• Performed Pharmacopoeial Surveillance for commercial products.

Tokyo, Jp, Jp

QA oversight of Stability and APQR systems. • Led a four-member team responsible for Stability and PQRs. • Reviewed and approved Stability Reports (for NDA Annual Report) and other technical reports. • Led cross-functional APQR review meetings; performed review and approval of APQRs. • Authored deviations, change controls and CAPA related to the stability and APQR systems. • Performed critical evaluation of stability data to ensure compliance with specifications and global regulations. • Standards of Excellence Award, 2012, for APQR system compliance.

Tokyo, Jp, Jp

Collect, review, analyze, trend, and report data for APQRs, and identify and communicate compliance risks to company management.• Collaborated with suppliers and internal employees concerning APQR data and identified issues. • Trended product quality complaints and reported to executive management. • Management of FDA and DEA National Drug Code (NDC) numbers system.

New Brunswick, Nj, Us

Temporary quality position supporting harmonization of material specifications globally into J&J’s electronic document management system.

Performed in-process monitoring of production and packaging operations (Floor QA). AQL inspection of finished product. Inspected and released raw materials and critical processing aids in the warehouse. Supported production of influenza vaccine, antivenin, and smallpox vaccine. QA on smallpox packaging line during Federal Smallpox Vaccine Mobilization. Scribe for FDA inspection of smallpox packaging line.

Master’S Degree, Qa/Ra

Master’S Degree, Curriculum And Instruction

Entomology

Bs, Entomology