Olabimpe Ayoola
Stafford,TX
Summary
In-Depth Quality Assurance Specialist with success in prioritization and multitasking. Exceptional communication and organizational skills. Committed to paying impeccable attention to reviews and auditing procedures.
Overview
9
9
years of professional experience
6025
6025
years of post-secondary education
1
1
Certification
Work History
Quality Assurance Specialist
Lonza Chemical and Biotechnological
Houston, Texas
08.2023 - Current
- Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function
- Demonstrates a high level of independent judgment and discretion in the timely identification, investigation, and resolution of events potentially impacting the quality of products and processes
- Reviews completed batch records for compliance to regulatory and Quva SOPs and to ensure product quality and safety standards are met
- Assist in working on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews
- Level 3 gown qualified
- Reviews routine manufacturing, environmental monitoring, and quality control data for in-process and finished products
- Sampling, inspection, and control of commercial product labels
- Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
- Ensures company compliance to QuVa Pharma Standard Operating Procedures (SOPs) and Quality Management System (QMS)
- Evaluation of batches / product for compliance with defined specifications
- Gathering Data to understand the aid in the accurate future determination of a RCA and development of determination
- Performs daily and weekly Environmental Monitoring, Viable and Non-Viable Air, Surface
Quality Assurance Specialist
THE PHARMACY
02.2018 - 08.2023
- Conducts cGMP virtual and questionnaire audits of suppliers in support of the supplier evaluation program and identifies / evaluates all risks
- Updates audit databases in a timely manner and generates status reports, as required
- Assures the company and vendor compliance with corporate policies, SOPs, and regulatory agency standards
- Identifies issues and mitigates corrective action, as required
- Identifies major cGMP compliance issues with suppliers and assist in the development of formal corrective action plans to be approved by management.
Quality Assurance Technician
ALCON AG
01.2017 - 02.2018
- Performing analyses, inspection, and tests of raw materials, packaging materials, finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property
- Performing a variety of qualitative tests or qualitative assays on samples to aid in maintenance and certification of test instruments and apparatus to ensure compliance
- Performing required inspections, checks, analysis, and documentation of studies• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions
- Classifies deviation investigations and assigns ownership to the appropriate Tris personnel for investigation completion
- Reviewing production records for conformance to procedures
- Conducting non-conformance tests of manufactured, packaged, or tested product• Evaluating non-conforming results and initiating re-sampling, re-testing, and/or hold procedures
- Perform QA on the floor activities.
- Conducted thorough inspections of products to ensure compliance with quality standards.
Education
Associate of Applied Science - Certified Nursing Assistant
Americans Medical Institute
Houston, Texas 09.2022 - 08.2023
Clinical Research Associate - Clinical Laboratory Science
Certified Course
03.2021 - 03.2021
Multi/Interdisciplinary - Multidisciplinary Studies
Houston Community College
Houston, TX 01.2017 - 06.2017
BSC - Business Administration
Institute of Management & Technology
NigeriaND - Science Lab.Technician
Akanu Abiam Federal Polytechnic
NigeriaHigh School Diploma -
Secondary Technical College
NigeriaSkills
- CGMP Compliance Knowledge
- Good Manufacturing Process (GMP)
- Quality Culture Mentality
- Problem Solving Skills
- Excellent Communication and Literacy
- Quality roles in Pharmaceuticals
- Proficient in computer software and Microsoft Office packages (Word, Power-point, Project, and Excel)
- Detail-oriented
Certification
- Pharmacy Technician Certification (CPhT)
- Two years of cGMP in the Pharmaceutical environment
- Intravenous Certification Specialist
- ACPE Sterile products Certification
- National Sterile Compounding Training
- Certified Associate in Soft Testing (CAST)
References
Available on request
Work Preference
Salary Range
$150000/yr - $200000/yrTimeline
Quality Assurance Specialist
Lonza Chemical and Biotechnological
08.2023 - Current
Associate of Applied Science - Certified Nursing Assistant
Americans Medical Institute
09.2022 - 08.2023
Clinical Research Associate - Clinical Laboratory Science
Certified Course
03.2021 - 03.2021
Quality Assurance Specialist
THE PHARMACY
02.2018 - 08.2023
Multi/Interdisciplinary - Multidisciplinary Studies
Houston Community College
01.2017 - 06.2017
Quality Assurance Technician
ALCON AG
01.2017 - 02.2018
BSC - Business Administration
Institute of Management & Technology
ND - Science Lab.Technician
Akanu Abiam Federal Polytechnic
High School Diploma -
Secondary Technical College