KHYATIBEN VYAS
Reston,VA
Summary
Skilled production operator with extensive experience in aseptic control and GMP protocols. Proficient in final product assembly and quality assurance with an emphasis on quality over quantity. Diligent, with a focus on safety, and a passion for learning, flexibility, team building, coaching, and training.
Overview
21
21
years of professional experience
Work History
Production Operator
Guerbet
- Documented production information via daily system logs and discussed issues with management.
- Set up and adjusted machines for day-to-day operations.
- Used equipment properly to avoid workplace hazards or injuries.
- Participated in training sessions to enhance skills and knowledge.
- Operate packaging equipment to package production within all applicable SOPS, CGMP, (Good Manufacturing Practice regulations) etc.
- Operate equipment within the validated parameter
- Perform 100% final inspection of units
- Label and package acceptable units.
- Follow and maintain documentation records, accountability of solution and units throughout production process.
- Check and verify components.
- Perform quality control duties, i.e. Sampling of product and environment.
- Clean/sanitize production and warehouse areas and equipment.
- Reducing product losses and improving yields Quality of product.
- Monitoring the process and documenting measurements per SOP.
- Compliance with FDA, OSHA, cGMP.
- Participation in all Safety aspects of the plant.
Sr. Tech, Operations
Merck
01.2022 - Current
- Assists Maintenance, Instrumentation and Automation during troubleshooting of common faults/errors.
- Performs housekeeping in all work areas. Executes facility sanitization and decontamination according to approved procedures.
- Completes in-process testing and inspections supporting vaccine manufacturing, validation, and development processes as required.
- Identifies and addresses compliance, environmental, safety, and process deviations as appropriate and escalates to appropriate personnel.
- Maintains, cleans and prepares equipment used in vaccine manufacturing process.
- Schedules and performs environmental monitoring during processing and records results in computerized database system. Provides timely delivery of samples and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.
- Attends and actively participates in safety & housekeeping walk-throughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
- Serves on safety, quality and other committees as required.
- Serves as subject matter expert within processing suite and trains new team members.
- Executes all documentation and clerical functions necessary for proper accountability and trace ability of product.
- Maintains, inventories, and transports all required processing equipment, materials, supplies and products needed to support manufacturing.
- Operates various computer-controlled process support/process equipment (i.e., washer, autoclave, vial filler, Lyophilization, capping/inspect machines, etc.).
- Performs process troubleshooting while maintaining production schedule.
- Executes equipment setup/breakdown, operational, and equipment inspections, as required.
- Works collaboratively with all operations and support personnel, performing manual and automated processing of vaccine manufacturing equipment, performing general troubleshooting tasks, and supporting functions necessary to produce vaccines.
General Manager
McDonald's Corp. Manning Enterprise
03.2003 - 12.2019
- Maximized efficiency by coaching and mentoring personnel on management principles, industry practices, company procedures, and technology systems.
- Managed budget implementations, employee evaluations, and contract details.
- Implemented operational strategies and effectively built customer and employee loyalty.
- Maximized operational excellence mentoring personnel on management principles, industry practices, and company procedures.
- Managed budget implementations, employee reviews, training, schedules, and contract negotiations.
- Drove year-over-year business growth while leading operations, strategic vision, and long-range planning.
- Developed and implemented strategies to increase sales and profitability.
- Formulated policies and procedures to streamline operations.
- Interacted well with customers to build connections and nurture relationships.
- Reported issues to higher management with great detail.
- Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
- Handled problematic customers and clients to assist lower-level employees and maintain excellent customer service.
- Reduced operational risks while organizing data to forecast performance trends.
- Scheduled employees for shifts, taking into account customer traffic and employee strengths.
- Assisted in recruiting, hiring and training of team members.
- Tracked employee attendance and punctuality, addressing repeat problems quickly to prevent long-term habits.
- Negotiated price and service with customers and vendors to decrease expenses and increase profit.
- Trained and guided team members to maintain high productivity and performance metrics.
- Implemented innovative programs to increase employee loyalty and reduce turnover.
- Supervised creation of exciting merchandise displays to catch attention of store customers.
- Implemented business strategies, increasing revenue, and effectively targeting new markets.
- Manage Staff of 47 employees and trained them.
Education
High School Diploma -
Southern High School, Durham NC
Durham, United States10.2022
IT Quality Analyses - Online
H2kinfosys
Bachelor of Business -
Hamburger University
Chicago, United States10.2010
Skills
- Material quality inspection
- ALCOA Principal Certification
- Aseptic Procedure Certification
- Equipment monitoring
- Quality Assurance
- MS Excel, MS Word, MS PowerPoint, Delta V/MES, GLIMS, SAP
- Operational Efficiency
- Performance monitoring
- Safety Education
- Defect Removal
- Quantity Verification
- Excellent Communication
- Forklift Training
- Good Manufacturing Practices
- Quality Control
Languages
Gujarati
Full Professional
Hindi
Full Professional
Spanish
Limited Working
English
Professional Working
VOLUNTEER EXPERIENCE
- Citizen Police Academy Training Durham Literacy Center Volunteer
- Ronald McDonald Charity Home
- Durham Tech Community College International Club,
- Activity Chair Representative
- Site(Merck) team as a Data Integrity Advocate Gig
Timeline
Sr. Tech, Operations
Merck
01.2022 - Current
General Manager
McDonald's Corp. Manning Enterprise
03.2003 - 12.2019
Production Operator
Guerbet
High School Diploma -
Southern High School, Durham NC
IT Quality Analyses - Online
H2kinfosys
Bachelor of Business -
Hamburger University
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