NICOLE MEDEIROS
Somerset,MA
Summary
Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
5
5
years of professional experience
1
1
Certification
Work History
New Product Specialist
American Bio
Canton
08.2020 - Current
- Piloted and implemented the creation of a new process to streamline inspection of kits.
- Researched and analyzed customer feedback to identify areas of improvement.
- Developed and implemented specialized procedures for handling magnetic beads and their respective products (Cytiva).
- Leveraged specialized knowledge to act as subject matter expert within organization including but not limited to internal and external customer products and processes.
- Coordinated with other departments (Supply chain, Production, Sales and Quality) to ensure efficient workflow processes at new product implementation.
- Conduct regular meetings with external customers to review feedback on new products and address any concerns.
- Organized client meetings to provide project updates.
- Conduct meetings with internal staff from other departments for risk assessment and feasibility of New Products and discuss driving towards project goal dates
- Manage new product timelines via project Gnatts
- Track project tasks associated with transfer to process owner (production manufacturing)
- Write and provide meeting minutes
- Utilized document management system to organize company files, keeping up-to-date and easily accessible data.
- Develop and maintain detailed plans and schedules for all tasks
- Identify project risk and risk mitigation
- Communicate deliverables with external partners
- Balanced competing priorities through deliberate project and time management practices.
- Train appropriate departments on all documentation created for new products
- Quote, Development and manufacture new products (medical devices) as a CDMO
- Design and execution of method and process validations
- Work with Validation Engineers on IQ/OQ/PQ and PV as the product SME
- New method, operational and technology transfers from external partners
- Coordinate with all internal groups for CAPA’s and continuous improvement projects
- Work with Supply Chain and Quality for the receipt of new unique raw materials
- Advise Supply Chain and production on expected time standards for new products
- Work with production for process improvement and feedback on process development
- Troubleshoot issues/conduct root cause analysis and recommend corrective actions
- Provide technical support for the manufacture and quality control testing of products
- Documentation creation (review and approval) and maintenance of records including BOM’s, Work Instructions, Deviations, Change Controls, labels, SDSs and SOPs
- Design Labels with appropriate GHS labeling
- Document and execute change requests received from external partners
- Creation and maintenance of new raw material info cards via ERP.
Second Shift Production Supervisor
American Bio
05.2020 - 08.2020
- Worked in the establishment of second shift & scheduling
- Responsible for training in cGMP and ISO
- Trained filling/packaging technicians and formulators
- Inventory maintenance and Printing batch tickets via ERP
- MasterControl EDMS
- Responsible for preventative maintenance
- Troubleshooting equipment and problem solving
- Run basic QC tests (pH, Density, Specific gravity, Conductivity)
- Performed QA inspection of finished goods per SOP and appropriate ANSI.
Formulation Technician
American Bio
01.2019 - 05.2020
- Manufacture and assemble biochemical and reagent products per GMP and ISO
- Calibration of pH meters
- Verification of scale calibration
- Trained new employees on scale calibration
- RO water system checks
- Autoclave, Pipetting, Filtering, Clean Room 5&7 experience
- Aseptic Technique
- Grounding and hazard room filling
- Biosafety Cabinet and Laminar Flow Hood experience.
Education
Bachelor of Science Degree in Biology -
Bridgewater State University
01.2018
Skills
- GMP/ISO 13485:2016 Certification
- Self Motivation
- Customer Relations
- Root Cause Analysis
- Plan, Do, Check, Act (PDCA), 5-Why Analysis, Ishakawa
- Proficient in MasterControl, ExESS, ERP ProcessPro, Excel, Word, Visio
- Project Planning
- Adaptability and Flexibility
- Time Management
- Multitasking
- Attention to Detail
- Task Prioritization
- Decision-Making
- Excellent Communication
- Continuous Improvement
- Process Improvement
- Organizational Skills
- Teamwork and Collaboration
Additional Work Experience
- Smokey Bones, Taunton, MA, Server and Bartender, 05/2016 - 03/2020
- Not Your Average Joes, Seekonk, MA, Server, 07/2017 - 04/2019
- Arpin Van Lines, West Warwick, RI, Customer Service and DP3 Move coordinator, Summers 2013 - 2015
Laboratory Skills
- PH adjustments
- Magnetic bead washing (Cytiva Beads)
- Titration
- Dilutions
- IR Spectroscopy
- NMR Spectroscopy
- PCR
- Gel Electrophoresis
- ELISA
- Hemacytometer
- Protein Extraction (cell lysis)
- Centrifugation
- Remel MICRO-ID System
- Endospore and Gram Staining
Coursework
- Genetics
- Cancer Biology
- Mammalian Reproduction Biology
- Medical Terminology
- Cell Biology
- Biochemistry
- Organic Chemistry
- Statistics
- Microbiology
- Medical Microbiology
Certification
Lean Six Sigma Green Belt 27Apr2024
PMI kickoff- Fundamentals of Waterfall Project Management 15Dec2022
Lean 101 Certificate 20Apr2022
Risk Management Course 19Nov2021
Affiliations
- Actively enrolled in Six Sigma Council for Lean Six Sigma Black Belt Certification.
- Enrolled in courses through PMI for continuous learning activities and to work towards a PMP.
- Enjoy continuously pushing myself whether through the gym, traveling solo, trying new experiences or crushing career goals to live the fullest life. I am actively preparing to hike Mount Kilimanjaro.
Timeline
New Product Specialist
American Bio
08.2020 - Current
Second Shift Production Supervisor
American Bio
05.2020 - 08.2020
Formulation Technician
American Bio
01.2019 - 05.2020
Bachelor of Science Degree in Biology -
Bridgewater State University
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