Data Entry Patient Care

Wanny Y. Cepeda

Email: ********@*****.*** Phone: 201-***-**** New Jersey

Objective

Motivated clinical scientist with 3 years of hands-on experience in, and a strong understanding of, the cGMP and FDA regulated sector seeking to utilize my skills and experience to transform my background into a career. Technical Skills

• Bilingual: Native proficiency in English and Spanish

• Understanding of CAR-T cell therapy production, gene therapy production and FDA regulated industry.

• Experience with processing cell cultures in an aseptic environment.

• Knowledge of EMRs, Microsoft Office (Outlook/Word/Excel), LIMS, MES, Oracle, and Data Analytics.

• Experience working with tube welders, tube sealers, sepax, clinimax, centrifuge, Beckman-Coulter multisizer cell counter, mettler-toledo balance, Fresnius-Kabi LOVO, pipetting, and electronic inventory management.

• Experience providing patient services such as vital signs, phlebotomy, EKG (set up and interpretation), specimen collection, medical dispensing, injection administration, surgery assistance, patient file management, appointment scheduling, patient care and education, nutrition, insurance verification and follow-up.

• Adept technical communication skills: capable of effectively articulating technical concepts in a clear and succinct manner to collaborate effectively within cross functional teams.

• Experience with medical and billing ICD 10 & CPT coding.

• Strong understanding of HIPAA, cGLP, GCP, cGMP, GDocP, GxP.

• Data Entry capabilities of up to 60 WPM.

Experience

Aseptic Operator Allendale, NJ

Minaris Regenerative Medicine Oct 2023 - Jan 2024

• Maintained cGMP compliance in essential training curriculum including standard operating procedures (SOPs), aseptic technique, gowning qualifications, and other relevant training.

• Collaborated with managers, leads, and fellow associates to guarantee timely and quality processing of clinical products while maintaining adherence to Good Manufacturing Practice (GMP) guidelines.

• Disinfected tools, equipment, and surfaces between work areas as well as processed expansion activities while adhering to proper aseptic technique and aseptic gowning protocol.

• Operated in a cleanroom (Grade C) environment for extended duration processing gene therapy products for use in clinical trials.

• Operated in the process support suite and Biological Safety Cabinet (BSC, Grade A environment) for extended durations as both operator and verifier, while adhering to proper aseptic technique and appropriate gowning protocol.

• Recorded production data and information following proper GDPs, as well as acted as reviewer for documentation recorded by fellow team members.

• Performed accurate arithmetic calculations, critical to the manufacturing process, when directed in the batch record.

Manufacturing Associate Summit, NJ

Bristol Myers Squibb Apr 2022 - Jan 2023

• Maintained cGMP compliance in essential training curriculum including standard operating procedures (SOPs), aseptic technique, gowning qualifications, and other relevant training.

• Worked extensive hours in a controlled cleanroom setting to process patient lots, consistently following aseptic gowning procedures.

• Collaborated with managers, leads, and fellow associates to guarantee timely processing of patient lots while maintaining adherence to GMP guidelines.

• Prepared equipment for daily use by conducting essential performance tests and daily checks, ensuring both the safety and sterility of operations in support of patient well-being.

• Prepared and reviewed all necessary documentation such as batch records and logbooks while following GDP guidelines, as well as acted as 1st and 2nd reviewer. Taqueria Los Gueros Passaic, NJ

Waitress/Hostess Feb 2019 - Sep 2019

• Responsible for training new team members.

• Maintained food preparation areas up to standard.

• Fulfilled orders.

EDUCATION

Passaic High School Passaic, NJ

High School Diploma Jun 2019

American Institute Newark, NJ

Medical Assistant Certification Dec 2021

Office of Dr. Focazio Clifton, NJ

Medical Assistant Intern Aug 2021- Feb 2022

• Performed multiple patient testing procedures including vital signs, COVID tests, EKG/ECG, bloodwork, and specimen collection.

• Documented and updated patient medical history.

• Prepared patients for gastrointestinal and esophagogastroduodenoscopy procedures.

• Maintained HIPAA compliance.

• Performed office duties such as diagnostic coding, filing insurance forms, bookkeeping, appointment scheduling, and documented correspondences with patients, insurance, and medical staff. CERTIFICATIONS

American Heart Association CPR/AED Oct 2020

American Heart Association BLS Certified Oct 2020

Medical Assistant Certification Program Present Dec 2021

Note- Am not a CDL certified person but I am a great driver and can drive up to 6 speeds manually

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