Rheya Beaton
Newark,DE
Summary
Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
15
15
years of professional experience
Work History
Quality Assurance Specialist II
Clene Nanomedicine, Inc.
North East, MD
11.2023 - Current
- Writes GxP documentation (i.e., SOPs, reports)
- Issues production batch records and associated packaging components per the Manufacturing schedule
- Performs room clearances
- Reviews controlled documentation for good documentation practices Quality monitoring of in-house manufacturing operations
- Supports the disposition of raw materials, intermediates, and drug products and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments
- Assists the Executive Director, Quality Assurance in developing and utilizing tools to perform risk assessment, track and report quality metrics to management for Quality Management Review
- Supports quality oversight of equipment, utility, and facility qualification activities
- Aid in implementing process improvements concerning Quality Assurance, including managing OOS procedures and related reporting
- Supports external agency and internal audits as required
- Supports the Document Control System
- Assist in the maintenance of the Document Control files (i.e., DCO Log); processes new/revised/retired documents in the current document management system.
Quality Assurance Specialist I
Clene Nanomedicine, Inc.
North East, MD
05.2022 - 11.2023
- Write GXP documentation (i.e., SOPs, reports)
- Issues production batch records and associated packaging components per the Manufacturing schedule
- Performs room clearances
- Reviews controlled documentation for good Manufacturing operations
- Quality monitoring of in-house manufacturing operations
- Supports the disposition of raw materials, intermediates and drug products and /or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments
- Assists the Executive Director, Quality Assurance in developing and utilizing tools to perform risk assessment, track and report quality metrics to management for Quality Management Review
- Support quality oversight of equipment, utility, and facility qualification activities
- Aid in implementing process improvements concerning Quality Assurance, including managing OOS procedures and related reporting
- Supports externals agency and internal audits as required
- Supports the Document Control System
- Assist in the maintenance of the Document control Files (i.e., DCO Log) processes new/revised/retired documents in the current document management system
- Working knowledge of cGMP principles concerning appropriate regulatory requirements (FDA, ICH guidelines)
- Ability and experience to identify technical manufacturing problems and suggest resolution of issues
- Ability to independently analyze/resolve moderate to complex issues
- Demonstrate initiative and accountability in a fast-paced environment
- Proficiency in application of QA principles, concepts, industry practices and standards
- Problem-solving skills, effective written and verbal communications skills
- Excellent documentation skills and attention to detail
- Highly organized and able to manage multiple priorities
- Ability to work independently and with various workgroups
- Working knowledge of MS office Suite (Word, PowerPoint, Excel).
Production Technician
Clene Nanomedicine, Inc.
North East, MD
01.2021 - 05.2022
- Responsible for producing and packaging products according to good manufacturing Procedures and maintaining good documentation practices in the process
- Responsible for maintaining a clean work environment, currently receiving training and instruction on various processes and procedures as it pertains to the manufacturing department and its operation and maintenance.
Manufacturing Inspector 2
Terumo Medical Corporation
01.2020 - 01.2021
- Responsible for managing and maintaining proper documentation from all departmental associates
- Making sure that safety procedures and safeguards are being adhered to according to OSHA and FDA requirements
- Making sure that associates are properly trained and providing training for associates in need of training
- Performing a variety of testing for products including tests done by the INSTRON device for parts produced in the department to ensure quality standards and safety
- Make sure associates have all the tools necessary to be able to do their jobs to the best of their ability while also maintaining safety and production procedures are being adhered to
- Compiling written reports and documentation regarding data, reviewing batch records and following good documentation practices and day-to-day activities as are required by Quality Assurance and Supervision
- Working closely with other PI's, Supervisors, Expeditors and Associates to ensure a safe, happy and cohesive work environment and experience.
Manufacturing Associate- Utility 1&2, Back UP Machine Operator
Terumo Medical Corporation
12.2017 - 01.2020
- Making and Assembling parts of medical devices
- Working individual and as a team to meet production requirements
- Cataloging and transfer of parts and materials electronically and physically
- Maintaining a friendly and productive work environment
- Tackling work related delays and machine troubleshooting according to safety guidelines
- Operating within the MHCS and MES system to ensure production materials and products are easily traceable and production can move forward easily
- Handle chemicals using proper PPE guidelines and procedures
- Fixing minor machine alarms and machine stops using proper available guidelines and procedures
- Operate adequately and efficiently SAM, M-Coat, STAM 2, STF, Bagger and Seal-IN Packaging Machine.
Store Clerk
Laramore of The Bahamas
San-Salvador, The Bahamas
08.2008 - 06.2011
- Operated a cash register for cash, check and credit card transactions with 100% accuracy
- Stocked and replenished merchandise according to store merchandising layouts
- Priced merchandise, stocked shelves and took inventory of supplies
- Cleaned and organized the store, including the checkout desk and displays
- Alerted customers to upcoming sales events and promotions
- Completed all point of sale opening and closing procedures, including counting the contents of the cash register
- Welcomed customers into the store and helped them locate items
- Used time efficiently when not serving customers, including folding clothes and cleaning out fitting rooms
- Resolved all customer complaints in a professional manner while prioritizing customer satisfaction.
Waitress/Hostess
Paradis Restaurant and Bar
San Salvador Island, The Bahamas
08.2008 - 06.2011
- Consistently provided professional, friendly and engaging service
- Skillfully promoted items on beverage lists and restaurant specials
- Followed all safety and sanitation policies when handling food and beverage to uphold proper health standards
- Displayed enthusiasm and knowledge about the restaurant's menu and products
- Routinely supported other areas of the restaurant as requested, including answering telephones and completing financial transactions for other staff
- Set dining tables according to type of event and service standards
- Addressed diner complaints with kitchen staff and served replacement menu items promptly
- Routinely cleaned work areas, glassware and silverware throughout each shift
- Developed and maintained positive working relationships with others to reach business goals
- Demonstrated genuine hospitality while greeting and establishing rapport with guests
- Guided guests through menus while demonstrating thorough knowledge of the food, beverages and ingredients
- Provided friendly and attentive service.
Education
High School Diploma -
San Salvador High School
General Studies Pre-BSN (Currently) -
Germanna Community College
Skills
- Organized and efficient worker
- Flexible and Committed team player
- Fast learner Courteous
- Professional demeanor
- High energy
- Manufacturing
- Quality Inspection
- Quality Assurance
- Mechanical Knowledge
- Documentation and Reporting
- Issue Resolution
- Materials Inspection
- Detail Oriented
- Regulatory Compliance
- Finished Product Inspection
- Team Collaboration
- Non-Compliance Assessments
- Internal Audits
- Sound Decision-Making Abilities
- Establishing and Enforcing Policy
- Quality Management Systems
- File Management
- Communication Proficiency
- Public Speaking
Timeline
Quality Assurance Specialist II
Clene Nanomedicine, Inc.
11.2023 - Current
Quality Assurance Specialist I
Clene Nanomedicine, Inc.
05.2022 - 11.2023
Production Technician
Clene Nanomedicine, Inc.
01.2021 - 05.2022
Manufacturing Inspector 2
Terumo Medical Corporation
01.2020 - 01.2021
Manufacturing Associate- Utility 1&2, Back UP Machine Operator
Terumo Medical Corporation
12.2017 - 01.2020
Store Clerk
Laramore of The Bahamas
08.2008 - 06.2011
Waitress/Hostess
Paradis Restaurant and Bar
08.2008 - 06.2011
High School Diploma -
San Salvador High School
General Studies Pre-BSN (Currently) -
Germanna Community College
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