Erica Wright

** ****** ****** ********, ********* Ga 30016 470-***-**** adz33i@r.postjobfree.com

Objective

To obtain a career in the professional field of Quality Assurance, with 5 years of experience; achieving organizational knowledge and developing awareness of career enhancement, improvements, and innovations to achieve best practices. Implementing my skills in customer service, with 5+ year of experience, communicating with others to solve problems and ensuring customer satisfaction. In addition, applying skills of technology from the knowledge obtained as a student at Strayer University, earning my Bachelor of Science in Information Technology.

Education

BACHLOR OF SCIENCE IN INFORMATION TECHNOLOGY MARCH 2023 STRAYER UNIVERSITY

Major: Systems and Network Administration

Minor: Technical Support

Related coursework: Data Science, Software engineering

Skills & Abilities

QUALITY TECHNICAL

Leadership

Organizational and planning

Communication

Analysis and Problem-Solving

Visual inspection

SQL, CFR’s, SOP’s

Compliance

Batch record reviews

CUSTOMER SERVICE

Telecommunications

Decisions-making and social skills

Patience

Detail oriented

Time management

Conflict resolution.

TECHNICAL

Programming languages

Operating systems

Data analysis

Project management.

LEADERSHIP

Elite Customer Service Agent for Dial America USA, Certified Visual Inspection trainer Takeda Pharmaceuticals, and CPR certified.

Experience

QUALITY ASSURANCE SPECIALIST SHIRE (TAKEDA PHARMACEUTIALS.) DATES FROM 7-2020- CURRENT

I was promoted to Quality Assurance Specialist. Daily activities implemented after transition includes, detailed and in-depth information on the visual inspection processes, AQL (Acceptable Quality Limits) sampling, revisions of SOP’s and job aids using Veeva Vault programming, answering alerts for the manufacturing processes using EBM (Electronic Batch Mgmt.) programming for our manufacturing process,, Ensuring all paper documents are in regulatory compliance with GDP (Good Documentation Practices) guidelines, working with JDE (JD Edwards) programming to ensure all controlled printed material has been accounted for, Certified for department training, Using track wise for creating deviations, using LIMS (Laboratory Information Management System) and Ramen programming for additional testing on our products, using 2D matrix Verification scanning to ensure the grade of our printed information is in compliance with the correct guidelines and specifications before our product is packed and disbursed to our patients.

Preforming final EBM Batch record reviews, by reviewing all the components of a WO, including associated PIs, alarms, alerts, UIs and verification that TrackWise events are generated and recorded in the batch record as required.

All Chapter’s and or Sup PIs associated to a Quality Review step have to be completed and executed.

All EBM Alerts for the process steps have been reviewed, answered, and closed.

Reviewed remarks associated with steps of the process has been verified and escalated if required.

If a TrackWise deviation was required, confirmed that the deviation was generated in TrackWise and the correct number was documented in the appropriate EBM Alert.

If User Interventions are required, I will ensure they have been completed, and referenced in the EBM Alert.

Confirmed PCS (Process Control System) Alarms have been reviewed and associated EBM Alerts has been closed and confirm that all the parameters within report are within range.

MANUFACTURING TECHNICIAN SHIRE (TAKEDA PHARMACEUTIALS) DATES FROM 4-2018-

7-2020(CURRENT)

Daily activities include preforming equipment setups, executing work orders, Lux meter testing, scanning in and out pallets, GDP documentation, GMP (GOOD MANUFACTURING PRACTICES) regulations to maintain a clean and organize work environment(6s), minor maintenance adjustments, certified visual inspector, inspecting fill and empty vials to insure they meet all SAP and SOP (Standard Operating Procedure) standards for the safety of our patients. Moving and storing supplies and product according to the job aid, Walkie Stackie certified, performing work tasks using EBM system instructions, Participate in Safety training courses for Captain of our safety committee in the IG (IMMUNE GLOBULIN) packaging area and actively involved in performing task on our packaging conveyor, to ensure all product is packaged according to SOP’s including (LOTO) lock out tag out certification.

QUALITY ASSURANCE SPECIALIST BARD MEDICAL DIVISION DATES FROM 2-201*-*-****

Completed all inspection requirements for surgical kits that included Saline and Lidocaine, before and after the assembly on a production line, utilized calibrated measuring instruments, technical drawings, SAP’s, and SOPs (Standard Operating Procedures) to perform various inspections for products and components, writing non-conformances and documenting all products and materials that failed to meet specifications.

CUSTOMER SERVICE REPRESENTATIVE DIAL AMERICA USA. DATES FROM 7-201*-*-****

Agent for answering all inbound calls which included taking reservations for Megabus routes, Subscribing, and taking care of all clients’ needs for the Wall Street Journal, and generating leads for Smart Boards and consulting for implementation for installments to be used in schools around the world. Within a year, I was promoted to and Elite team member. I then began handling all escalated calls from agents that needed further assistance.

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