ADESUBOMI SHITU
Philadelphia,PA
Overview
4
4
years of professional experience
Work History
Quality Specialist (Contract)
Merck
Westpoint, PA, PA
07.2023 - Current
- Becomes fully trained in relevant Standard Operating Procedures (SOPs) and competency-based activities Learns cGMPs, the manufacturing process, and our Company quality systems, including SAP, GLIMS and electronic logbook, laboratory data, and batch record platforms
- Reviews production documentation such as batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
- Review and Approve Fit Test Reconciliations
- Collaborates with cross-functional team members to ensure batches are ready for release by appropriate due dates and executes the appropriate quality checks and SAP transactions required
- Responsible for routine auditing of GMP practices, documentation, and data
- Review/approve new and updated SOPs and Controlled Job aides
- Actively participates in the Tier process and use this forum to make concerns visible and to partner with the functional area on resolution
- Responsible for review/approval of new and updated Master Batch Records
Quality Specialist (Contract)
Johnson & Johnson
Fort Washington, PA
02.2022 - 03.2023
- Performs review of all inputs to execute Batch Release as well as performing review of Manufacturing Batch Records and associated documentation.
- Performs SAP transactions required to document Batch Record and Critical Site review.
- Performs GMP walk through inspections of assigned departments within organizations to ensure compliance with cGMPs and regulatory requirements, including aseptic areas.
- Coordinating shop floor activities of production and supporting departments to ensure standards of safety, quality and efficiency are met.
- Working with the Line Leads and Production Management to ensure product and process quality related to daily production flow.
- Monitoring and reporting defects attributed to their areas through direct interface with the environment.
- Implementing process improvements to improve quality and productivity levels.
- Ensures proper identification of release status and control of materials through maintenance of quarantines in the SAP system and through physical tagging of material as required.
- Performs Quality review / approval of new and updated SOPs and CJAs.
- Collaborates with members from other support groups within the functional organization, such as Operations, Technology, and Scheduling, in the identification and implementation of continuous improvement initiatives and action plans.
- Works with necessary groups within the functional area to resolve outstanding issues with process documents / logbooks, GMP walk through inspection observations, and quarantine management:
- Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
- Developed and implemented procedures to meet product quality standards.
Quality Control Analyst
Rentschler BioPharma
07.2020 - 01.2022
- Review pertinent documents, records, and reports such as manufacturing batch records, lab test results against SOPs for accuracy and compliance to procedures based on good documentation practice
- Maintained compliance using Master Control to ensure high quality of product and document management activities to improve decision making
- Ensure FDA Final Disposition requests received from Regulatory, and Suppliers are managed in a timely manner
- Support in the development, testing of drug procedures using Jira, as well as operating microbiological and analytical instrumentation's.
- Performing inspections, tests and evaluations of medical products and materials
- Taking daily environmental readings and perform weekly maintenance on water systems.
- Created test plans for incoming raw materials prior to use in production lines.
- Conducted audits of internal systems, processes, products and services in order to assess their effectiveness.
- Collaborated with cross-functional teams to develop solutions for identified issues related to product or service quality.
- Monitored production processes to ensure compliance with established quality control standards.
- Performed routine maintenance and calibration on testing equipment.
- Developed training materials, SOPs and work instructions to supplement new team member onboarding.
Education
Master of Science - Drug Development
Liberty University
Lynchburg, VA05-2024
Bachelor of Science in Biology -
RHODE ISLAND COLLEGE
05.2021
Skills
- SAP
- PAS-X
- GLIMS
- Master Control
- MS Office tools
- Data/ Input Entry
- Risk Management
- Test Results Interpretation
- Documentation And Reporting
- Inventory Control
- Analytical Thinking
- Project Management
Timeline
Quality Specialist (Contract)
Merck
07.2023 - Current
Quality Specialist (Contract)
Johnson & Johnson
02.2022 - 03.2023
Quality Control Analyst
Rentschler BioPharma
07.2020 - 01.2022
Master of Science - Drug Development
Liberty University
Bachelor of Science in Biology -
RHODE ISLAND COLLEGE