Alyssa Sabatino
Warwick,RI
Summary
Professional in manufacturing with proven ability to drive process improvements and ensure quality production. Expertise in operating and maintaining machinery, adhering to safety protocols, and optimizing workflows. Strong focus on team collaboration and adaptability, consistently delivering reliable results under changing conditions. Adept at troubleshooting issues and implementing solutions efficiently.
Overview
7
7
years of professional experience
Work History
Manufacturing Associate-ARI5 Upstream Inoc/Seeds
Amgen
09.2023 - Current
- Operation and monitoring of critical GMP Upstream processes including non-routine procedures
- Proficient with on the floor testing
- (pH, Osmo glucose, lactate)
- Utilizes manufacturing software DeltaV, MES, LIMS, PI Historian, CDOCS, and MS Office
- Successfully signed off on all operations in Inoc/Seeds
- Lead process tasks
- Track wise Access
- EBR Access
- MES Access
- Maximo Access
- Initiate/ work on Deviations/ TR’s
- Demonstrated versatility adaptability taking different roles responsibilities assigned including machine operator, quality inspector, or material handler.
- Collaborated effectively with cross-functional teams to troubleshoot issues, optimize processes, and achieve common goals.
Manufacturing Associate- Purification
Amgen
01.2022 - 09.2023
- Operation and monitoring of critical GMP downstream processes including non-routine procedures
- Proficient with on the floor testing
- (Solo VPE, pH, Osmo, PTS Endo)
- Utilizes manufacturing software DeltaV, MES, LIMS, PI Historian, CDOCS, and MS Office
- 5s Lead D-Shift
- Followed safety protocols and utilized OSHA-approved PPE to foster safe working environment.
- Organized work to meet demanding production goals.
- Operated various types of machinery efficiently while adhering to all safety protocols at all times during shifts worked alongside other employees working together towards shared objectives.
- Collaborated with team members to meet production deadlines.
- Recorded and tracked daily production data for management reporting.
Manufacturing Associate- Purification (Contractor)
Takeda Pharmaceuticals
09.2021 - 01.2022
- Operation and monitoring of critical GMP downstream processes including non-routine procedures
- Proficient with on the floor testing
- (Solo VPE, pH, Osmo, PTS Endo)
- Utilizes manufacturing software DeltaV, MES, LIMS, PI Historian, CDOCS, and MS Office
QC Analyst I (Contractor)
Takeda Pharmaceuticals
04.2021 - 07.2021
- Performed analytical testing such as pH, Recon, and A280 in accordance with SOPS and cGMP guidelines
- Cleaned and provided general housekeeping in the lab in accordance with 5S guidelines
- Prepared reagents to be used in assays
- Maintained chemical inventory including documenting supply and status of stocked reagents and checking expiration dates
- Calibrated, standardized, cleaned and maintained laboratory analyzers and equipment with proper GDP documentation including DU800 Spectrophotometer and pH meter
- Performed extensive data analysis and management using Microsoft Excel
Trauma Intensive Care Unit Secretary
Rhode Island hospital
04.2019 - 04.2021
- Compiled physical and digital documents, charts and reports to meet business and patient need
- Employed online tracking systems to manage medical supply inventory, insurance records, patient charts and company files
- Scheduled and confirmed patient appointments for diagnostic, surgical and consultation services
- Maintained office supplies inventory by checking stock and ordering new supplies as needed
- Answered 50 average daily phone calls to schedule appointments and address patient inquiries
- Digitized over 500 medical records and organized files in Life Chart
- Managed physician calendar, including scheduling patient appointments and procedures
- Updated patient financial information to promote accurate record keeping
- Gathered information to file appeals for denials and minimized inaccuracies by maintaining accurate records of approvals
Transporter
Rhode Island hospital
10.2017 - 04.2019
- Compiled physical and digital documents, charts and reports to meet business and patient need
- Employed online tracking systems to manage medical supply inventory, insurance records, patient charts and company files
- Scheduled and confirmed patient appointments for diagnostic, surgical and consultation services
- Maintained office supplies inventory by checking stock and ordering new supplies as needed
- Answered 50 average daily phone calls to schedule appointments and address patient inquiries
- Digitized over 500 medical records and organized files in Life Chart
- Managed physician calendar, including scheduling patient appointments and procedures
- Updated patient financial information to promote accurate record keeping
- Gathered information to file appeals for denials and minimized inaccuracies by maintaining accurate records of approvals
Rental Car Driver
Christy’s Auto Rentals
07.2018 - 01.2019
- Transported clients and packages to specified destinations safely and on-time
- Completed order forms and collected payments to keep customer accounts current
- Consulted with customers to gain feedback and address concerns with products or services
- Inspected vehicle before and after every trip to assess performance and maintenance requirements
- Updated customer financial information to promote accurate record keeping
- Gathered information to file appeals for denials and minimized inaccuracies by maintaining accurate records of approvals
- Contacted insurance companies for insurance information & settlements
Education
Bachelor of Science - Magnetic Resonance Imaging (MRI) Technology
Rhode Island College
Providence, RIAssociate of Arts -
Community College Of Rhode Island
Warwick, RI05.2019
Skills
- Aseptic Sampling
- AVEVA PI System
- Liquid Chromatography (LC);Solo-VPE
- Trackwise System - Nonconformance/CAPA
- Chromatography/ UFDF/ Buffer preparation /Final Filtration Certified
- Viral Filtration (DV50, NFR, VPro, Planova)
- Single Use Systems
- Flexible manufacturing Pipetting
- Electronic Batch Record Review (eBR)
- Single-Use Systems (SUS)
- Osmolality Testing
- Acid Base Titrations
- Vacuum Filtration;Aseptic Operations
- EBR (WERUM) SoftwareLaboratory Information Management System (LIMS)
- DeltaV
- Single Use Technology
- Endotoxin Testing
- Project Planning
- PPE Use
- Data Management
- Multitasking
- Friendly, positive attitude
- Microsoft Office
- Critical Thinking
- GMP guidelines
- GDP guidelines
- Basic Analytical Chemistry Assays
- Time Management
- Lab Support and Documentation
- Reliable and Trustworthy
- Training & Development
- Flexible Coordination
- Customer Service
Timeline
Manufacturing Associate-ARI5 Upstream Inoc/Seeds
Amgen
09.2023 - Current
Manufacturing Associate- Purification
Amgen
01.2022 - 09.2023
Manufacturing Associate- Purification (Contractor)
Takeda Pharmaceuticals
09.2021 - 01.2022
QC Analyst I (Contractor)
Takeda Pharmaceuticals
04.2021 - 07.2021
Trauma Intensive Care Unit Secretary
Rhode Island hospital
04.2019 - 04.2021
Rental Car Driver
Christy’s Auto Rentals
07.2018 - 01.2019
Transporter
Rhode Island hospital
10.2017 - 04.2019
Associate of Arts -
Community College Of Rhode Island
Bachelor of Science - Magnetic Resonance Imaging (MRI) Technology
Rhode Island College