Quality Assurance Manufacturing Operations

FRANK OPOKU

770-***-**** / ad0ocr@r.postjobfree.com / ad0ocr@r.postjobfree.com

PROFESSIONAL PROFILE

A highly skilled professional bringing forth 6 years of experience in Quality Assurance and Pharmaceutical Manufacturing Operations. Having handled various materials and substances while working in laboratory settings. A driven individual with a keen eye for detail and the ability to keep projects moving forward. Highly organized with exceptional interpersonal skills allowing for clear and concise communication that facilitates cohesive work environments. Recently finished a Master of Science degree in International Biomedical Regulatory Sciences which has allowed for the gain of immense field knowledge and expertise in Regulatory Affairs.

Change Management, and Document Control professional. Quality Assurance, Regulatory, Clinical Research, and Biotechnology/Pharmaceutical Professional. Extensive knowledge of FDA and global health regulations. Broad background throughout product development and product commercial life cycle. Knowledge in Biologics, Medical Devices, and Combination Products.

PROFESSIONAL EXPERIENCE

Regulatory Affairs Specialist (Entry Level) 06/2021 to Present

Dendreon Pharmaceutical LLC

Union City, Ga

oMaintaining capabilities to recognize and resolve unfamiliar problems and formulating strategies to validate them.

oAssisting in the development of regulatory standards and SOPs

oMaintenance of batch-to-batch (from clinical to commercial lots) consistency per CMC

oEnsuring appropriateness and accuracy of product information

oKnowledge in regulatory standards outlined by FDA and ICH

oSubmissions of data, files and regulatory documentations per eCTD supported by ESG

oChange control expert with quality in mind

oStrong communication and time management skills aiding with on-time submissions

oGreat attention to details resulting in great safety and efficacy data for quality products

oInternal and external auditing experience – Vendors, Third Party Logistics

oContinuous collaboration with stakeholders as well as CMOs for all regulatory concerns

oEnsuring the appropriate up-to-date records are maintained for compliance.

oSupporting in delivering timely approvals and product information in keeping with the needs identified by our company and market in compliance with company procedures and local country regulations.

oSupporting my company with my knowledge of America’s regional regulatory procedures and legislation.

oConduct Clinical audits on our clinical team on all procedures for quality - GCP.

Manufacturing Quality Assurance Specialist 06/2017 to 05/2021

Dendreon Pharmaceutical LLC

Union City, Ga

oQuality Assurance compliance project lead for Research and Development for Routine Commercial manufacturing ensuring quality oversight for CMO partners.

oResponsible for Quality Assurance of Development Products and Technical Transfers.

oProvide technical review and guidance on quality compliance issues (deviations, change control, supplier management etc.) as QA representative in CMC cross-functional project team.

oIdentifying/investigating GMP deviations/investigations.

oCAPA investigations, Process Improvements and timely CAPA closures effectiveness checks.

oProviding regulatory expertise on regulatory submissions, health authority briefing and response documents

oApplication of strict aseptic techniques in daily cell processing of clinical and commercial products adhering to company’s SOPs

Technical Skills

FDA Regulatory knowledge

Analytical skills

Organizational skills

Time Management Skills

Leadership & Development, Stakeholder Management, and Cross-Functional Collaboration

Solid knowledge in Quality documentation processes and systems engineering in healthcare systems.

Technical writing, including writing of Quality Agreements, and Investigation reports.

Quality Systems Regulations (QSR 21CFR 820), Medical Devices (ISO 13485) and Quality Management Systems (ISO 9001)

Proficient in FDA, ICH, ISO, cGMP, GDP and GCP regulations

Knowledge of product quality complaints and adverse event investigation

Project Management skills experience with Sipuleucel-T immunotherapy

Electronic Systems and Software

Adobe Acrobat, Digital, Veeva Vault, COSMOS, SAP, DocuSign, Master Control, Compliance wire, ERPLx, LIMS, MS Excel, Outlook, MS word, Microsoft Teams, and MS Power Point).

CATsWeb

oComplaints,

oDeviations/Actions/Effectiveness Check (EC)/ Laboratory Investigation Report (LIR)

oWriting Deviation Reports in CATsWeb

oCAPAs (investigation and elimination of nonconformances, correct, prevent, and improve)

oChange Controls

oSupplier Quality Management (SQM)

VeeVa Vault Quality – GxP Document Management System

Vault RIM (Regulatory Information Management System)

oUse Objects (Regulatory Reportability Assessments -event activities) to capture information and data related to products (change that needs to be assessed for regulatory reports for a specific country or global).

SAP – Batch Release, Perform QA review, QA release for shipment, Communication.

Customer Service Manager 04/2005 - 05/2017

Walmart Inc

Marietta, GA

oAwarded the best customer service manager for July 2012 and August 2016 due to exceeding company expectations

oManaged all customer inquiries and performed conflict management effectively

oUtilized effective communication skills to correspond with team and clients promptly

oOversaw and mentored over 100 hourly associates through their assigned duties and improved productivity and work performance of the team

oPerformed training of new staff members and ensured skill level was adequate for unsupervised work

oOrchestrated data entry and performance of advanced machinery and equipment

oCoordinated daily communication via telephone and face to face

Laboratory Assistant (Part Time) 05/2013 - 04/2015

Kennesaw State University

Kennesaw, GA

o Identified areas of improvement that effectively increased laboratory efficiency and lowered cost by inventory management resulting in approximately $2000 in savings per year.

oPrioritized quality control in all lab protocols including sanitation standards, testing procedures, and all SOPs

oTested and prepared chemical solutions, reagents, and specimens for microscopic examination

oHandled 50lb weights regularly by maneuvering around the lab for preparation of various procedures

oExecuted laboratory testing, analyzed data, and prepared presentation of data in the form of pivot charts or excel

oConducted laboratory research in microbiology, biotechnology, chemistry, biology, and human physiology

EDUCATION

Master of Science: Pharmacy, Concentration in International Biomedical Regulatory Sciences

College of Pharmacy 2022

University of Georgia

Bachelor of Science: Biology 2016

Kennesaw State University

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