Quality Assurance Analyst

Herold Mimy

Pharmacy Manufacturer Quality Assurance Analyst

786-***-**** Miami, FL ******.****@*****.*** linkedin.com/in/herold-mimy/

PROFESSIONAL SUMMARY

Extensive experience in pharmaceutical, biotechnology, and clinical diagnostic industries. Dedicated to precision in pharmaceutical manufacturing while upholding FDA Regulations, cGMP, and safety protocols to deliver high-quality products efficiently. Passionate about ensuring a safe work environment and exceeding production standards.

AREAS OF EXPERTISE

Detail Oriented

Mechanical Aptitude

Equipment Specialty

Managing Change

Critical Thinking

Team Collaboration

Analytical Skills

Manufacturing

Quality Leadership

PROFESSIONAL EXPERIENCE

Quality Assurance Specialist October 2023 – January 2024

GBI Biomanufacturing, Plantation, FL

Performed quality assurance duties relating to studies performed under GLP/GMP/CGMP compliance.

Participated in the development, implementation, and maintenance of quality systems per GLP, GMP and CGMP regulations to ensure the best quality of products manufactured, packaged and delivered.

Reviewed quality related documents, including study protocols, study reports, OOS investigations, validation reports, and other relevant documents as needed.

Developed controlled documents and procedures pertinent to quality assurance and operations activities.

Worked cross functionally in identifying and resolving quality issues as they present themselves while exercising judgment within defined procedures and practices to determine appropriate action.

Supported the preparation and coordination of inspections by regulatory authorities and clients and trained employees on revisions of procedures and the implementation of such procedures.

QA Specialist April 2021 – January 2023

Adma Biologics, Boca Raton, FL

Ensure the manufacturing of high-quality pharmaceutical products per production schedule within established SOP that are made with multiplicity of materials and assembled on a high-speed highly automated production line.

Responsible for compliance with SOPs and policies for the release of plasma pools, by writing, reviewing and revising Quality assurance documentation.

Prepared daily shift performance reports and participated in pre-shift team hurdles to discuss day-to-day performance metrics and provide input on product quality, equipment deficiencies and operational excellence.

Worked with cross functional teams to identify quality issues as they present themselves within defined procedures and practices to determine appropriate action before completing critical phases.

Customer Service Representative December 2019-March 2021

Insurance Savers, Miami, FL

Managed a high-volume of inbound and outbound calls, maintaining a customer satisfaction rate of over 90%.

Maintained detailed knowledge of company products and services, ensuring accurate and helpful customer support.

Resolved customer issues by applying problem-solving skills and providing timely solutions for questions about life, car and home insurance products.

Implemented feedback mechanisms, which increased customer engagement and provided valuable insights for service improvements.

Achieved a personal customer follow-up rate of 85%, ensuring issues were resolved and customers were satisfied with the service.

Manufacturing Specialist II October 2015 – November 2019

Teva Pharmaceuticals, Davie, FL

Specialist authorized to verify and give clearance in the primary area for product transfer to scale up production.

Operated machines (blender, tablet press and encapsulation machines) to mix or blend any of a wide variety of materials, such APIs, chemicals, and any other powder.

Read work orders to determine production specifications or information to ensure safe and efficient operation.

Performed all equipment change-over, set-ups and adjustments for equipment of responsibility in a safe and effective manner per defined work standards.

Adjusted machine components, machine tension and pressure according to size and processing angle of product.

Kept the tablet press lubricated and clean during tablet run and maintained accurate records of testing usage and inspections.

Ensured the proper removal of finished products from machines while separating rejected items following standard grading qualifications.

Maintained and reviewed all logbooks and batch records with a keen eye on specific details on number of batches made, the number of raw materials used to become finished goods.

Provided input for enhancing efficiencies and modifying SOPs to ensure accuracy, top quality and improved productivity.

Wurster Column Operator/Dry Dosage September 2001 – September 2015

Teva Pharmaceuticals, Davie, FL

Expert in Standard operating procedures for manufacturing a variety of different HPLC and Wurster columns packing different sorbents.

Prepared packing solvents and slurry solvents for material verification and Inspection for multiple drugs.

Performed data entry tasks using TSA and AX computer systems.

EDUCATION

Bachelor of Science, Health Services Administration, Barry University, Miami, Florida

Certificate in HR, Barry University, Miami, Florida

Associate of Science, Pharmacy, Miami Dade Community College, Miami, Florida

LICENSES AND CERTIFICATES

Florida Notary American Red Cross First Aid

Operational Excellence Certified White Belt Emergency Response First Responder

2015 South Florida Manufacturing Association Employee of the year

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