Roseline Osei-Mensah
Hamilton,OH
Summary
GMP processes and quality systems expert with over 4 years in quality assurance. Skilled in reviewing and approving GMP documentation, including batch records and validation protocols, while effectively collaborating with cross-functional teams. Experience at National Resilience and Nitto Avecia strengthened capabilities in CAPA resolution and audit processes. Dedicated to ensuring product quality and safety in compliance with regulatory standards and organizational objectives.
Overview
13
13
years of professional experience
Work History
Associate II, Quality Assurance
National Resilience
10.2023 - Current
- Maintained a high level of understanding of relevant production processes and quality systems.
- Performed the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: Change Requests, Batch Records and associated documentation, Product and Component Release transactions in SAP, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports, Standard Operating Procedures.
- Collaborated with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
- Executed QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.
- Interfaced with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects.
- Collaborated with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices.
- Stayed abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders.
- Collaborated in data analysis and report creation on quality metrics and key performance indicators.
Quality Assurance Specialist
Nitto Denko Avecia
08.2021 - 10.2023
- Effectively communicate and maintain positive relationships with departments to resolve noncompliance issues and close CAPA on-time and analyze practices for maximum efficiency.
- Supervised auditing of establishments and determined scope of investigation required. Prepared detailed reports on audit findings, asset utilization and audit results. Recommended changes in operations for increased quality and efficiency. Completed production reports to notify management of production levels.
- Reviewed and approved master batch records, labels, specifications, and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirement.
- Review executed production batch records, environmental monitoring data (as required), and associated documentation, including any deviation and investigation reports related to lot release of Clinical/Commercial Drug Product in support of product disposition.
- Lead or coordinate investigations and corrective and preventive action (CAPA) recommendations.
- Interface directly with contract manufacturers and alliance partners to manage quality related issues with minimal supervision.
- Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial Drug Products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.
- Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.
- Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Write, revise, and review standard operating procedures.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Works with Research and Development during new product start-ups and identifies checkpoints for new products and processes.
- Normally receives very little instruction on routine work, general instructions on new assignments.
- Assist in departmental planning activities to ensure that deliverables are provided according to project timelines.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Quality Assurance ASP
Kroger Logistics
02.2021 - 04.2021
- Perform Quality Assurance document review for all incoming products conform to written and approved quality specifications.
- Perform inspections on inbound products following company guidelines and written specifications (SOP).
- Communicate with buyers and the Merchandising department on inventory levels, short-dated product, shrink, and other quality-related issues on a timely basis.
- Check Brix, pressure levels, and pulp temperatures on inbound produce.
- File claims on an out-of-spec product that stays in the distribution center (DC) and follow company guidelines and procedures for filing and recording claims; communicate claims to Merchandising, Procurement, and vendors.
- Reject product that is out of temperature or dating guidelines; communicate that information to immediate supervisor, Merchandising and Procurement staff.
- Be actively involved in the banana ripening process and ensure bananas are shipping to stores at the proper stage and temperature.
- Participate in Quality investigations and Risk assessment of produce.
- Work with the vendor community and WESCO in identifying/correcting any quality issues.
- Keep inspection area sanitized and thermometers/scales calibrated.
- Perform short date surveillances daily on most volatile products and once per week on longer shelf-life products.
- Direct drivers or warehouse services (WSS) to pull random samples throughout the truck on straight loads by company guidelines; take samples to be inspected to the Quality Assurance (QA) area.
- Maintain ground beef log and temperature logs to provide information on any foodborne illness’s point of origin.
- Identify improperly rotated product and correct the rotation issue with the help of the supervisor.
- Assign QA status(sellable/purge/Donate) and also perform activities that will prevent produce from purging.
- Investigate all routine problems that occurred during the assignment.
- Check produces freshness every day to confirm freshness of produce before it gets to customers.
Quality Analyst
AstraZeneca
07.2020 - 04.2021
- Performed QA review on Batch Records and associated documentation.
- Performed QA review and approval on Product and Component Release transactions in SAP(QA Hold, Release, Rejected/Quarantined/Impound).
- Learnt how to do Quality Investigations (Deviations, CAPA Management, Product Complaints).
- Reviewed Validation Plans, Protocols, and Reports.
- Edited/Reviewed Standard Operating Procedures.
- Executed QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.
- Interfaced with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects.
- Conducted visual inspection of vials and cartons of vaccines.
- Paid diligence to safety.
- Primarily responsible for Quality Activities for manufacturing in a controlled environment. This included Quality inspection, checks, tests, and sampling of in-process materials, parts, and components used in the manufacture of a finished pharmaceutical product.
- Performed AQL inspection of pharmaceutical products at different stages including Inspection of In-process Materials in a light booth per company standards.
- Performed QA review and approval of GMP documentation.
- Executed quality issue resolution to maintain the flow of products and documents to meet site objectives.
- Used ANSI/ASQ Z1.4 sampling plans to perform inspections.
- Did all AQL Inspection of Components and Packaging Inspections.
- Performed visual Inspection – Inspecting Materials for Defects, Components: Vials, Stoppers, Seals. Packaging: Labels, Cartons, Inserts.
- Held others accountable for high standards and clarifies what needs to be accomplished.
Operator 1
Teva Pharmaceuticals
Cincinnati, Ohio
05.2019 - 06.2020
- Learnt the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP).
- Mastered Set up, changeover, programming, and operation of various equipment in the manufacturing and/or packaging area including, but not limited to, Thermoformers Applicator feeder, cartoner, and check weigher.
- Learnt how to Clean facilities, equipment, and utensils as required following SOP’s.
- Completed all documentation as required in the manufacturing and/or packaging of the product including MES/SAP transactions.
- Completed all training requirements and maintained 100% compliance with all assignments.
- Maintained work areas and performed job functions safely and efficiently by company policies and procedures, current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s), and Batch Record instructions (BRI).
- Performed additional related duties as assigned. Such as root cause analysis, completing determination sheets, reviewing batch records, good issuing materials for the next job, reviewing the end of job documentation.
- Championing all TPM tasks on the line and making sure we are doing our CIL’s according to our SOPs.
- Tasked to perform activities such as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts, and/or operation of machines (including inspection). Also Used measurement devices and/or assembly or fabrication of parts at a distance or close to the eyes.
Business Development/Project Manager
Work Health and Safety Organization
09.2012 - 03.2018
- Company Overview: Ghana
- Work with Trainer on Training and certifying companies on ISO certification (e.g., ISO 9001, ISO 18001, ISO 14001). Also teaching the QA team on QMS software for their operations i.e., Track wise, EAM, and Oracle.
- Conducting safety and occupational health audits of manufacturing entities (e.g., Diageo GH, Ayrton Drugs, Latex Foam Products, Interplast GH, Nestle GH.).
- Training and certifying employees of clients on HSE.
- Coordinated internal resources and third parties/vendors for the flawless execution of projects and ensured that all projects were delivered on time, within scope and budget.
- Developed a detailed project plan to monitor and track progress while ensuring resource availability and allocation.
- Prepare all proposals for marking and presentation purposes.
- Ghana
Education
Six Sigma Green Belt - Certificate
Star 6 Sigma Global Academy
12.2022
Agile Scrum Professional - Certificate
Star 6 Sigma Global Academy
11.2022
The Agile Project Manager - Certificate
Star 6 Sigma Global Academy
11.2022
DISC Leadership Manager - Certificate
Star 6 Sigma Global Academy
11.2022
MBA - Project and Quality Management
California Intercontinental University -CIU
09.2022
Yellow Belt Certification - Certificate
Teva Pharmaceuticals- Cincinnati Ohio
07.2019
ISO 21500 Lead Implementer Project Management -
Professional Evaluation and Certification Board (PECB)
Canada10.2016
Bachelor of Science -
Ghana Institute of Management And Professional Administration (GIMPA)
Greater Accra, Ghana06.2015
Health and Safety Certification -
NEBOSH International General Certificate and Occupational Safety and Health UK
UK08.2013
Some College (No Degree) - Cerificate
Teva Pharmaceuticals- Cincinnati Ohio
Skills
- Medical Device-ISO 13485
- Proficient in MS Office programs
- OpEx and Optel Trained
- Basic knowledge of USP
- Basic knowledge of cGMP
- Basic knowledge of FDA regulations
- Six Sigma Green Belt Trained
- Deviation/CAPA/Continuous Improvement
- Systems Experience
- Veeva Vault
- Workday
- Aveva
- RTIP
- PAS/X
- JIRA
- Lab Vantage
- Velocity EHS
- SAP
- One Drive
- MODA
- Office SharePoint
- Adobe
- Microsoft Office
- MES
- Track wise
- Lead Auditor
- QA skills and Knowledge
- TPM - Autonomous Maintenance
- MES/SAP Trained
- Performing qualitative and quantitative
- Veeva Vault Trained
- CAPA
- GMP compliance
- Quality investigations
- Batch record review
- Regulatory compliance
- Standard operating procedures
- CAPA management
- Product disposition
- Data analysis
- Process improvement
- Risk assessment
- Effective communication
- Audit preparation
- Stakeholder engagement
- Team collaboration
- Time management
- Attention to detail
- Multitasking and organization
- Problem resolution
- Computer skills
- Problem-solving
- Adaptability and flexibility
- Decision-making
- Leadership qualities
- MS office
- Problem-solving abilities
- Workplace safety
- Customer interaction
- Customer engagement
- Task prioritization
- New hire training
- Preparing reports
- Multiple priorities management
- GXP
Systems Experience
- Veeva Vault
- Workday
- Aveva
- RTIP
- PAS/X
- JIRA
- Lab Vantage
- Velocity EHS
- SAP
- One Drive
- MODA
- Office SharePoint
- Adobe
- Microsoft Office
- MES
- Track wise
Affiliations
- Starting up women's ministry from scratch and managing and heading that ministry
- Head the Host and Hostesses department at church
- Handling all event from planing to execution at church
References
References available upon request.
Timeline
Associate II, Quality Assurance
National Resilience
10.2023 - Current
Quality Assurance Specialist
Nitto Denko Avecia
08.2021 - 10.2023
Quality Assurance ASP
Kroger Logistics
02.2021 - 04.2021
Quality Analyst
AstraZeneca
07.2020 - 04.2021
Operator 1
Teva Pharmaceuticals
05.2019 - 06.2020
Business Development/Project Manager
Work Health and Safety Organization
09.2012 - 03.2018
Six Sigma Green Belt - Certificate
Star 6 Sigma Global Academy
Agile Scrum Professional - Certificate
Star 6 Sigma Global Academy
The Agile Project Manager - Certificate
Star 6 Sigma Global Academy
DISC Leadership Manager - Certificate
Star 6 Sigma Global Academy
MBA - Project and Quality Management
California Intercontinental University -CIU
Yellow Belt Certification - Certificate
Teva Pharmaceuticals- Cincinnati Ohio
ISO 21500 Lead Implementer Project Management -
Professional Evaluation and Certification Board (PECB)
Bachelor of Science -
Ghana Institute of Management And Professional Administration (GIMPA)
Health and Safety Certification -
NEBOSH International General Certificate and Occupational Safety and Health UK
Some College (No Degree) - Cerificate
Teva Pharmaceuticals- Cincinnati Ohio
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