Diagnostic Technician with 10+ years of experience in regulated manufacturing of molecular diagnostic products and reagents within GMP/cGMP environments. Experienced in supporting production operations, including work in the Filling Department. Knowledgeable in following SOPs, GMP standards, safety procedures, and Good Documentation Practices while maintaining a strong focus on quality and compliance.
Overview
21
21
years of professional experience
Work History
Diagnostic Technician – Manufacturing / Production
ROCHE MOLECULAR SYSTEMS
Branchburg Township, New Jersey
08.2012 - 01.2023
Facilitated manufacturing of molecular diagnostic products and reagents in a GMP/cGMP environment, ensuring adherence to established procedures and quality standards.
Worked with plasma-based materials used in diagnostic products for STI testing and products supporting COVID-19 testing.
Performed manufacturing activities in the Filling Department within controlled room environments, following SOPs, gowning practices, PPE requirements, and contamination control procedures.
Executed maintenance of batch records and manufacturing documentation per Good Documentation Practices, ensuring compliance and accuracy.
Reviewed and reconciled batch records to ensure accuracy, completeness, and compliance with manufacturing requirements.
Conducted visual inspections and collected samples for QA testing, evaluated materials against established specifications and acceptance criteria.
Managed material tracking and reconciliation in SAP to support inventory accuracy and streamline manufacturing transactions.
Identified and communicated production or documentation discrepancies and collaborated with Manufacturing and Quality teams to support timely resolution and compliance.
Warehouse Assistant / Picker Packer
TOP KNOPS – USA
09.2007 - 09.2010
Executed picking, packing, labeling, and order preparation for timely shipment.
Supported inventory organization, material handling, and order fulfillment to ensure operational efficiency.
Recorded shipping and inventory data accurately to maintain compliance and track stock levels.
Followed workplace safety procedures and established company standards.
Pharmacy Technician / Assistant Manager
FISCHEL – SAN JOSÉ, COSTA RICA
SAN JOSÉ, COSTA RICA
01.2002 - 05.2007
Managed inventory activities to ensure timely ordering, receiving, and stocking of pharmaceutical products.
Inspected medication storage locations to monitor expiration dates and maintain adequate inventory levels.
Prepared prescription transfers to other pharmacies efficiently.
Received and verified daily incoming drug inventories, reporting discrepancies and logging items into inventory system.
Assisted pharmacists with preparation and dispensing of medications to patients.
Coordinated daily operations with team members to support efficient workflows.
Optimized pharmacy operations to enhance patient and client experience.
Education
General Educational Development (GED) -
Skills
Manufacturing protocols and SOP adherence
GMP and CGMP compliance
Good documentation practices
Quality control, batch record review and reconciliation
Filling and controlled room operations
Visual inspection and sampling
SAP data entry
PPE practices
Material reconciliation
LANGUAGES
Spanish: Native, English: Advanced
Timeline
Diagnostic Technician – Manufacturing / Production
Manufacturing Technician/Manufacturing Production Associate at Apeel Sciences Biotechnology ResearchManufacturing Technician/Manufacturing Production Associate at Apeel Sciences Biotechnology Research