Stephanie Rai
Stoneham,MA
Summary
Highly motivated and detail-oriented with 12+ years experience in diverse GMP industries including Biotechnology, Semiconductor Lithography, Pharmaceutical, and Medical Device. Self-motivated and quality driven with a demonstrated history of learning new processes, equipment, and technology quickly and effectively.
Overview
18
18
years of professional experience
Work History
Certified Childcare Provider
Self Employed
Stoneham, MA
06.2023 - Current
- Maintained daily records of children's individual activities, behaviors, meals, and naps.
- Ensured compliance with state regulations and center policies by maintaining a clean, organized environment and adhering to health and safety guidelines.
- Managed classroom effectively to maintain a structured, positive learning environment for all children.
- Improved parent satisfaction through consistent communication and collaboration on child progress.
- Maintained accurate records of each child''s progress, attendance, health concerns, and developmental milestones.
- Developed age-appropriate activities to support cognitive, social, and physical development in children.
- Utilized creative problem-solving skills to address conflicts among children, promoting peaceful resolutions and teaching conflict resolution strategies.
- Enhanced children''s emotional well-being by providing a safe and nurturing environment.
- Prepared healthy foods and beverages for children based on optimal dietary guidelines and individual restrictions.
- Facilitated learning through play, stories and outdoor activities for successful child outcomes.
- Worked with children to develop good cognitive, physical and language skills.
Senior Manufacturing Associate
Oncorus Inc
Andover, MA
11.2021 - 05.2023
- One of two of the first on site manufacturing team members to help create, organize, and prepare a brand new Biotech manufacturing site.
- Created, edited, and submitted revisions to controlled documents in Veeva in support of cGMP Operations.
- Prepared, reviewed and/or audited technical documentation supporting cGMP Operations.
- Assisted in writing master batch records and prepared MBR templates for routine drug product manufacturing activities.
- Facilitated improvements to manufacturing documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented.
- Collaborated with subject matter experts.
- Partnered with Product Development and Manufacturing Engineering to transfer equipment to manufacturing and create written content.
- Responsible for all manufacturing documentation i.e., SOP’s, production records, checklists, forms, logbooks, etc.
- Worked with manufacturing teams to generate process maps and then convert to SOP.
- Demonstrate ability to write original material.
- Performed multiple triple cleanings in brand new manufacturing suites and multiple graded rooms.
- Performed cleaning of fixed process equipment in process rooms.
- Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products.
- Organized and prepared workstations and materials needed for operations to maximize productivity.
- Followed safety protocols and utilized OSHA-approved PPE to foster safe working environment.
- Assisted in training team members in aseptic gowning and operation techniques.
Manufacturing Associate
Amgen
Woburn, MA
08.2020 - 10.2021
- Lead Operator for shift of 10 employees during site startup after over a year of dormancy.
- Primary BSC operator for activities including: Cell Culture, Seeding, Viral INfection, and Harvest Operations.
- Performed operations for Freezing, Buffer, Autoclaving, Assembly Build, and Visual Inspection of final product.
- Primary trainer for shift operations pertaining to Autoclaving, Buffers, Freezing and Visual Inspection.
- Qualified operator for Fill/Finish operations including preparation and sanitization of fill machine, automated filling and associated manual interventions and aseptic sampling of filling environment.
- Document (SOP) owner/author.
- Assisted with decontaminating and decommissioning manufacturing related equipment for permanent site shutdown.
Manufacturing Associate
Amgen
Woburn, MA
08.2017 - 07.2019
- Perform operations for drug substance and drug product operations according to Standard Operating Procedures (SOP's).
- Perform and monitor critical processes, execute routine protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOP's, and technical reports.
- Perform basic troubleshooting, evaluate product quality, and assist in the review of documentation for assigned functions.
- Assisted in identifying, recommending, and implementing improvements related to routine functions.
- Assisted in identifying, recommending, and implementing improvements related to routine functions.
- Assisted DMS (Document Management Systems) with document reconciliation and the subsequent scanning, filing and archival of controlled documents.
- Prepared and provided Production Documentation upon request.
- Assisted in the process of decommissioning manufacturing machinery for site-shutdown and complete document relocation.
Compliance Specialist
Sanofi Genzyme
Allston, MA
07.2015 - 03.2017
- Primarily responsible for reviewing and reconciling assorted manufacturing logbooks from multiple departments.
- Ensure quality expectations are being met in the areas of Good Manufacturing, Good Distribution Practice and Good Documentation Practice.
- Experience with data review for accuracy, completeness and compliance.
- Review documentation for cGMP compliance and product quality.
- Responsible for managing own workload from multiple project managers to meet deadlines.
- Actively participated in the planning and prioritization of multiple projects and/or the resolution of quality and compliance.
Wafer Fab Operator
Skyworks Solutions Inc
Woburn, MA
06.2014 - 07.2015
- Perform a variety of functions in the production of semiconductor wafers in a cleanroom environment
- Operate advanced wafer processing- photolithography equipment for wireless industries.
- Perform set-up, calibration and preventative maintenance tasks on wafer fabrication equipment.
- Operate multiple tools used to expose and develop images onto wafers along with testing and inspection to ensure the quality of the wafers.
- Responsible for monitoring equipment operation, inspecting final product, cleaning the work environment, and performing data entry.
- Utilized high powered microscopes to inspect wafers during and after photolithography processes.
Packaging Technician II
Upsher-Smith
Plymouth, MN
02.2010 - 07.2011
- Independently clean, set-up, operate, and monitor a variety f semi-automated and automated packaging equipment in accordance with high standards of quality.
- Responsible for routine machine adjustments, component changes, minor mechanical troubleshooting, process improvements, and equipment changeovers.
- Responsible for collection of data related to production process including inventory, supplies, machine status and accurate labeling of products.
- Carefully reviewed instructions and guidelines with each unique product made to ensure proper handling and packaging is prepared.
- Maintain full compliance with cGMP, FDA, Batch Records, SOP's, and OSHA requirements.
- Carefully tracked and recorded any changes in procedures, equipment changes and product quality.
Manufacturing Team Member
Medtronics, Inc.
Brooklyn Park, MN
03.2006 - 07.2009
- Built and inspected components for medical devices under production processes and procedures.
- Worked with new research and development products and produced reports that reflected the effectiveness of the materials or tools used to make the products.
- Trained and certified new employees on manufacturing process as well as existing co-workers that needed recertification.
- Measured and reported on training effectiveness and sought feedback from employees. Updated the training programs to ensure manufacturing requirements are clearly delivered to employees.
Education
General Studies
Bunker Hill Community College
Charlestown, MAHigh School Diploma -
Sierra High School
Colorado Springs, COSkills
- Document Formatting
- Document Review
- Batch Record Review
- Quality Management Systems
- Records organization and review
- GMP Regulations
- Team Collaboration
- Detail Oriented
- Quality assurance awareness
Timeline
Certified Childcare Provider
Self Employed
06.2023 - Current
Senior Manufacturing Associate
Oncorus Inc
11.2021 - 05.2023
Manufacturing Associate
Amgen
08.2020 - 10.2021
Manufacturing Associate
Amgen
08.2017 - 07.2019
Compliance Specialist
Sanofi Genzyme
07.2015 - 03.2017
Wafer Fab Operator
Skyworks Solutions Inc
06.2014 - 07.2015
Packaging Technician II
Upsher-Smith
02.2010 - 07.2011
Manufacturing Team Member
Medtronics, Inc.
03.2006 - 07.2009
General Studies
Bunker Hill Community College
High School Diploma -
Sierra High School