Quality Assurance Mental Health

AWUSIGI S YAHAYA

SUMMARY OF ACHIEVEMENTS

Hardworking, highly driven, meticulous healthcare professional with years of experience in mental health, managing others, healthcare administration, and five plus years’ proving strong analytical skills in the Drug Safety and Pharmacovigilance field. Consistently achieved high quality work, maintained magnificent work ethics and confidentiality. Improved office efficiency by staying up to date on new techniques, technology and updating database which Improved quality standards for better quality performance and reliability. I apply such knowledge very efficiently to every task assigned with proven excellence in cross- functional teams, and collaborations. In addition to that, I am adaptable, have excellent communication skills and the ability to multitask.

PROFESSIONAL DEVELOPMENT

The Protection of Human Research Subjects - Good Clinical Practice CITI course (2017- 2024)

The Protection of Human Research Subjects - Track 1 (biomedical) CITI course (2024) National Institutes of Health: Information Security Awareness (2017-2024) AREAS OF EXPERTISE

Oral/Written Communication Skills

Plan, Prioritize and Meet Deadlines

Excellent Time Management

Good Document Practices (GDP)

Good Manufacturing Practices (GMP)

Quality Assurance and Control (QA and QC)

Pharmacovigilance (PVG)

Organization, Analytical and Critical Thinking

Confidentiality and Discreetness

Data Management

Strong Ethical Behavior

EXPERIENCE

2024-April-Present Kite Pharma-Gilead

Quality Assurance Operation-Specialist I

• Provide QA support on the floor for production in manufacturing and in the QC labs.

• Ensure process control measures are in place and followed in product manufacturing.

• Perform apheresis accession of incoming patient material.

• Receipt, perform accession, and disposition of incoming patient material.

• Perform shipment authorization of final product.

• Verify and ensure timely issuance of production documents and labels.

• Review batch-related documentation and ensure resolution of issues to release and ship product.

• Real-time review of exceptions, Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs) on the manufacturing floor.

• Gather and report metrics to measure performance.

• Gather and report metrics to measure performance.

• Identify and participate in continuous improvement actions.

• Ensure timely resolution and escalation of issues.

• Ensure quality records are initiated for deviating events are observed on the floor.

• Ensure products are manufactured in compliance with regulatory and GMP Guidelines.

• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.

• Additional duties as assigned.

• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

2022-2024 Technical Resources International, Inc.

Quality Assurance Specialist

• Supports and maintains the Quality Management System (QMS).

• Maintains the Quality Assurance (QA) training program, document control, customer complaint program and Corrective and Preventive Actions (CAPA) program.

• Follow-up on CAPA’s.

• Participation in Risk Management process and support to team in identification of risks.

• Participates in clinical site and vendor/supplier audits.

• Excellent comprehension of GCP, GCLP, and Good Pharmacovigilance Practice (GVP).

• Supports, prepares for, and participate in GCP, GVP, and GCLP regulatory inspections, including mock and actual inspections.

• Reviews inspection deliverables.

• Supports and participates in internal audit program and performance metrics system for continual improvement of the QMS.

• Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations.

• Pre-approve document change, assign effective dates and routes for review and approval in the electronic Document Management System (DMS).

• Responsible for filling and maintenance of controlled documents and records.

• Ensure files easily retrievable and accurate.

• Perform general word processing tasks.

• Review document formats and templates.

• Review clinical plans and provide support.

• Ensure accurate and timely input of database entries.

• Manages the review cycle of QA controlled documents to assure practices reflect written procedures.

• Maintains and tracks the monitoring report daily.

• Ensures that performance and quality products conform to established company and regulatory standards.

• Escalate issues to management that affect the quality and regulatory compliance.

• Collaborate on projects, provide support and assistance as needed on cross functional teams. 2016– 2022 Safety Quality & Pharmacovigilance Associate III

• Manage the Division of AIDS (DAIDS) Regulatory Support Center (RSC) Safety Information Office (RIC) front-end activities including monitoring the RIC electronic mailbox and incoming faxes.

• Effectively manages safety information distribution tasks for the DAIDS contract.

• Perform Quality Control of distributions and manages safety information daily including Safety Reports, Safety Memos, Investigator’s Brochures (IB), Package Inserts (PI), Data and Safety Monitoring Boards (DSMBs), Patient Safety Reports (PSRs), and Development Safety Update Reports (DSURs). Diligently performs monthly and quarterly reviews of safety information (IBs and PIs) to ensure versions are up to date.

• Maintain the DAIDS RSC website that provides safety information and documents related to safety information. Review all safety files and client deliverables.

• Assist in developing guidelines and procedures for monitoring international programs activities.

• Assist as needed in the coordination and arrangement of meetings and workshops.

• Develop and maintain spreadsheets and other administrative databases related to programs and project activities.

• Responsible for filling and maintenance of controlled documents and records.

• Ensure files easily retrievable and accurate.

• Perform general word processing tasks.

• Review monthly and quarterly contract reports for client, as well as generate reports as requested.

• Maintain and support the review of internal work instructions.

• Review work instructions, promote quality, and provide training support of the Quality Management System (QMS).

• Provide data entry support for Serious Adverse Events (SAEs) in the DAIDS Adverse Experience Reporting System (DAERS) system as requested by clinical sites.

• Responsible for DMID front-end tasks including Argus case book-in and generating daily/weekly reports for the team as well as client. Efficiently prioritize my tasks across the contracts and complete tasks in a timely manner without compromising on quality.

• Consult with different areas of business to understand reporting requirements and produce reporting outputs to match.

• Escalate issues to management that affect the quality and regulatory compliance.

• Support the DAIDS TMFs to meet regulatory requirements in Veeva Vault and supply guidance on quality systems to other functional areas.

• Collaboration with leads to reconcile TMF documents received for completeness and accuracy.

• Utilizes acquired knowledge in performing various intricate tasks.

• Collaborate on projects, provide support and assistance as needed on cross functional teams.

• Participate in cross-functional team meetings, working groups, training sessions to support program initiatives and perform task-oriented training of new and existing staff. EDUCATION

-Kaplan University, Master of Health Care Administration-(Organizational behavior, Leadership, Theory, Human Resource, and Development as they apply to the Healthcare Industry)

-Bowling Green State University, Bachelor of Arts and Science, (Psychology Minor) COMPUTER SKILLS

-Hardware: Intel-based PC

-Software: Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe Acrobat Reader and Creative Cloud), Division of AIDS Adverse Event Reporting System (DAERS), Voyager and Voyager Plus (Protocol Management (PM) and Protocol Development Tracking (PDT)), Pegasus (Master Contact), PubMed, Track Wise/Master Control, ARGUS, Veeva Vault, eTMF (Electronic Trial Master File), Quality Control, Medical Terminology, SPSS-(IDX/HER,

Centricity EMR, ICD 9/10 and CPT Coding), OHM- Occupational/Employee Health Record System, Google Doc-Basic, Internet Explorer, Facsimile, Teams, One Drive, Kite Konnect, PAS-X, GVault

LANGUAGES

-Twi- Fluent-Functional, Hausa-Fluent-Functional, and Ga-General

Contact this candidate