Continuous Improvement Team Member

Heena Rana

973-***-**** • *************@*****.***

Experience

BRISTOL MYERS SQUIBB SPECTRAFORCE SUMMIT WEST, NJ 26 MAY 2025 – PRESENT MSS-ENVIRONMENTAL- CAR-T MONITORING ASSOCIATE

KEY RESPONSIBILITIES:

• RESPONSIBLE FOR PERFORMING SAMPLE ANALYSIS, PRINTING OF BATCH LABELS, AND CREATING EM SAMPLE PLANS.

• RESPONSIBLE FOR RETRIEVING SAMPLE PLATES, SANITIZATION OF EM EQUIPMENT AND DOCUMENTATION IN LOGBOOKS.

• RESPONSIBLE FOR COLLECTION OF SAMPLES PER SAMPLE PLAN.

• RESPONSIBLE FOR DELIVERY OF SAMPLES TO QC MICROBIOLOGY.

• RESPONSIBLE FOR WORKING IN COMPLIANCE WITH ESTABLISHED SAFE WORK PRACTICES AND PROCEDURES; PROPERLY USES PERSONAL PROTECTION AND SAFETY EQUIPMENT AS REQUIRED BY BRISTOL MYERS SQUIBB (BMS)

• REPORTS ANY INJURY OR ILLNESS IMMEDIATELY AND NOTIFIES BMS OF ANY HAZARDS, UNSAFE ACTS OR CONDITIONS IN THE WORKPLACE

• PERFORMS ROUTINE PROCESSES FOLLOWING WRITTEN INSTRUCTIONS (SOP’S) IN SUPPORT OF THE PRODUCTION OF PHARMACEUTICAL PRODUCTS WITH ADHERENCE TO FDA OR CGMP GUIDANCE

• WORK IN AN ASEPTIC PRODUCTION ENVIRONMENT

• MUST BE ABLE TO WEAR APPROPRIATE CLEAN ROOM ATTIRE (I.E. SURGICAL MASKS, STERILE GOWN) AND ALL PERSONAL PROTECTIVE EQUIPMENT (PPE)

• RESPONSIBLE FOR ACCURATE COMPLETION OF ALL EM SAMPLING DOCUMENTATION

• OPERATE AND MAINTAIN EQUIPMENT AND WORK AREA TO ENSURE CLEANLINESS AND SAFETY FOLLOWING GMPS AND SOPS

• ENSURE THAT MATERIALS AND EQUIPMENT IN THE MANUFACTURING AREA ARE MAINTAINED IN ACCORDANCE WITH GMPS AND SOPS

• CONTRIBUTE TO ACHIEVING CONTINUOUS IMPROVEMENT

• MUST WORK INDEPENDENTLY WITH MINIMAL SUPERVISION

• MUST SUCCESSFULLY COMPLETE TRAINING ON ASEPTIC GOWNING PROCEDURES AND DEMONSTRATE THE ABILITY TO ASEPTICALLY GOWN

• ENSURE COMPLIANCE WITH CURRENT GOOD MANUFACTURING PROCEDURES (CGMP), USP, EU, AND OTHER GLOBAL REGULATORY REQUIREMENTS AT ALL TIMES.

• FOLLOW DIRECTIONS PROPERLY AND WORK COOPERATIVELY AS AN INDIVIDUAL CONTRIBUTOR AND AS A TEAM MEMBER.

• COMMUNICATE EFFECTIVELY WITH MANUFACTURING OPERATIONS PEERS, CROSS-FUNCTIONAL PEERS, AND MANAGEMENT.

• ASSIST IN TROUBLESHOOTING AND SOLVING PROBLEMS THAT MAY COME UP IN THE DAY-TO-DAY OPERATION OF THE DEPARTMENT.

• PERFORM ENVIRONMENTAL MONITORING ON A ROUTINE AND NON-ROUTINE BASIS FOR ALL S12 & S16 GMP MANUFACTURING AND ASSOCIATED WAREHOUSE AREAS.

• ASSIST WITH INVESTIGATIONS & CAPAS ASSOCIATED WITH EM EXCURSIONS.

• PERFORM ALL OTHER DUTIES AS ASSIGNED.

ATLANTIC HEALTH SYSTEMS MORRISTOWN, NJ APRIL 2024 TO MAY 2025 CLINICAL LAB ASSISTANT-ACL

•PATHOLOGY GROSS ROOM

• PERFORMING ASEPTIC ACTIVITIES WITHIN CLEANROOMS AND MODULES WHEN HANDLING SAMPLES.

• ACCESSES, LABELS, AND PROCESSES LABORATORY SPECIMENS

• PERFORMS ACCURATE PATIENT REGISTRATION. FOR OUTPATIENT LABORATORY SPECIMENS

• ASSURES PROPER COLLECTION, COMPLETION, AND REPORTING OF TESTS ORDERED

• REVIEW PENDING LOGS AND INVESTIGATE/RESOLVE OUTSTANDING ISSUES FROM ALL AHS HOSPITALS AND OUTPATIENT FACILITIES

• INVESTIGATES PROBLEMS AND MISSING SPECIMENS

• REVIEWS AND ORDERS SEND-OUT TESTS FOR REFERENCE LABORATORIES

• ASSISTS IN THE TRAINING OF TEAM MEMBERS WITHIN THE DEPARTMENT

• ENSURES SUPPLIES ARE STOCKED IN ALL PATHOLOGY AREAS

• MAINTAINS ESTABLISHED DEPARTMENTAL POLICIES, PROCEDURES, QUALITY IMPROVEMENT, SAFETY, AND ENVIRONMENTAL/INFECTION CONTROL STANDARDS

• SUPPORTS IN INVENTORY MANAGEMENT

• SUPPORTS FREEZE-DRYING PROCESSES, PACKAGING, LABELING, FINAL CLEANING LOG DOCUMENTATION, AND OTHER RELATED TASKS.

• PROFICIENT IN EXECUTING ASEPTIC TECHNIQUE WHILE HANDLING SPECIMENS TO PREVENT CROSS-CONTAMINATION FROM PATHOGENS.

• IMPLEMENTED INVENTORY CONTROL BY MANAGING MATERIAL EXPIRY, ALLOCATION, AND KITTING TO ENSURE THAT BATCH RECORDS WERE PROPERLY KITTED/STAGED BASED ON THE PRODUCTION SCHEDULE. • CONDUCTED ALL NECESSARY PROCESSING OPERATIONS TO ENSURE ADHERENCE TO SOP GUIDELINES. • FACILITATED MATERIAL CONDITION REQUIREMENTS/ROUTINE EQUIPMENT CLEANINGS TO ESTABLISH REPORTING BASELINES WITH THE INTENT OF OPTIMIZING WORKFLOW AND PROCESS IMPROVEMENTS.

• WORKED THROUGH CONSTRAINTS TO STEWARD VARIOUS PROJECTS TO COMPLETION BY REVIEWING PENDING LOGS AND RECOGNIZING OPPORTUNITIES FOR IMPROVEMENT.

QUEST DIAGNOSTICS CLIFTON, NJ JUNE 2022 TO APRIL 2024 PATHOLOGY IMMUNOHISTOCHEMISTRY (IHC) LAB AIDE/HISTOLOGY TECH

• PROVIDED A WIDE VARIETY OF SUPPORT FOR ASSIGNED LAB DEPARTMENTS.

• PERFORMED ASEPTIC ACTIVITIES WITHIN CLEANROOMS AND MODULES WHEN HANDLING SAMPLES.

• PICKED UP SAMPLES FROM ACCESSIONING AND SORTED SAMPLES INTO APPROPRIATE RACKS.

• UNPACKS AND STORES REAGENTS AND SUPPLIES

• INVENTORIES AND ORDERS WAREHOUSE SUPPLY ITEMS

• SORTED SAMPLES AND DISTRIBUTED THEM TO THE APPROPRIATE SETUP HOOD.

• MANAGED SPECIMEN LIBRARY WITHIN ESTABLISHED TIME FRAMES.

• PERFORMED WAIVED TESTS UNDER SUPERVISION

• IMMUNOHISTOCHEMISTRY (IHC) LOOKING FOR POSITIVE CANCER

• PROCESSED AND EMBEDDED TISSUES, CUT TISSUE BLOCKS, AND MOUNTED CUT MATERIAL ON SLIDES. • STAINS AND COVERSLIPS SLIDE FOR ROUTINE H&E, SPECIAL, AND IHC STAINS.

QUEST DIAGNOSTICS CLIFTON, NJ JUNE 2018 TO JUNE 2022 PHLEBOTOMIST

•COLLECTED SPECIMENS ACCORDING TO ESTABLISHED PROCEDURES. THIS INCLUDES, BUT IS NOT LIMITED TO, DRUG SCREENS, BIOMETRIC SCREENING, AND INSURANCE EXAMS. VENIPUNCTURE DRAW, CAPILLARY DRAW. PEDIACTRIC BLOOD DRAW. WITHDRAWS NEEDLE, APPLY TREATMENT TO PUNCTURE SITE AND LABLE TUBES.

• RESEARCH TEST/CLIENT INFORMATION AND CONFIRM AND VERIFY ALL WRITTEN AND ELECTRONIC ORDERS BY UTILIZING LAB TECHNOLOGY SYSTEMS, CLIENT CONTACT, AND APPROVED TOOLS.

• THE ABILITY TO NAVIGATE A COMPUTER AND ACCURATELY ENTER DATA IS A REQUIREMENT TO BE SUCCESSFUL IN THIS ROLE.

•OBTAINED IDENTIFICATION AND ACCURATELY ENTERED BILLING INFORMATION AND COLLECTED PAYMENTS WHEN REQUIRED, FOLLOWING CORPORATE POLICIES.

•PROCESSING SPECIMENS, INCLUDING LABELING, CENTRIFUGING, ALIQUOTING, FREEZING, AND PREPARING FOR TRANSPORT AS REQUIRED BY THE TEST ORDER.

• PERFORMED ALL NON-PATIENT-FACING DUTIES, INCLUDING INVENTORY, STOCK SUPPLIES, SANITIZING, FILING, ANSWERING PHONES, AND UTILIZING EMAIL AS APPROPRIATE.

• READ, UNDERSTAND, AND COMPLY WITH DEPARTMENTAL POLICIES, PROTOCOLS, AND PROCEDURES.

• ASSISTED WITH THE COMPILATION AND SUBMISSION OF STATISTICS AND DATA WHEN REQUIRED.

• MAINTAINED ALL APPROPRIATE PHLEBOTOMY LOGS IN A TIMELY MANNER AND BASED ON FREQUENCY, SUCH AS MAINTENANCE LOGS AND TEMPERATURE LOGS.

SUMMIT MEDICAL GROUP BERKELEY HEIGHTS, NJ JANUARY 2020 TO NOVEMBER 2021 PATIENT SERVICE REPRESENTATIVE/COVID-19 SCREENER

• MAINTAINED AN EFFICIENT PATIENT FLOW THROUGH THE REGISTRATION PROCESS AND PROVIDED EXCELLENT CUSTOMER SERVICE TO PATIENTS/FAMILIES.

• ACCURATELY RECONCILES DAILY PAYMENTS. RECONCILED BILLING SLIPS TO THE DAILY SCHEDULE.

• SCANS THE INSURANCE CARD, PROCESSES INSURANCE VERIFICATION UTILIZING THE ONLINE SYSTEM, AND UPDATES THE PATIENT ACCOUNT.

• UPDATED PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, INSURANCE, HIPAA FORMS, AND FINANCIAL WAIVERS.

• MONITORED AND SCREENING TEMPERATURE

• ANSWER QUESTIONS WORKERS MAY HAVE REGARDING CORONAVIRUS OR SOCIAL DISTANCING.

• PROVIDED EDUCATION REVOLVING AROUND ISOLATION AND QUARANTINE PRACTICES TO PREVENT FURTHER COVID-19 CASES.

RIVERSIDE MEDICAL GROUP CLIFTON, NJ DECEMBER 2018 TO JANUARY 2020 MEDICAL ASSISTANT-PAIN MANAGEMENT

• RESPONSIBLE FOR ALL CLERICAL DUTIES, INCLUDING MANAGEMENT OF PATIENT APPOINTMENTS AND PERFORMING INSURANCE VERIFICATION AND PRE-AUTHORIZATIONS FOR MEDICATIONS.

• MEASURED AND DOCUMENTED THE PATIENT’S VITALS AND GLUCOSE LEVELS.

• MANAGED POST-ANESTHESIA CARE UNIT (PACU) PRE-REGISTERED PATIENTS FOR PROCEDURES AND FOLLOWED UP ON POST-PROCEDURES.

• WORKED WITH OTHER HEALTH FACILITIES TO OBTAIN IMAGING AND LAB REPORTS PER PHYSICIAN’S REQUEST.

• MAINTAINED THE PRIVACY OF PATIENTS’ HEALTH RECORDS RECEIVED IN ACCORDANCE WITH HIPAA. • HANDLED DAILY REQUEST TRACKING, RESEARCHING OPERATIONAL ISSUES, AND RUNNING REPORTS FOR INTERNAL AND EXTERNAL CLIENTS UPON REQUEST; PROVIDED DOCUMENTATION RELATED TO THE COMPLETION OF ASSIGNED TASKS AND IDENTIFIED OPERATIONAL OR PRODUCTIVITY ENHANCEMENTS.

• PROVIDED OPERATIONAL SUPPORT FOR ASSIGNED ESI MARKETS (COMMERCIAL, MEDICARE, HEALTH PLAN, ETC.) FOR ONGOING PLAN CHANGES, NEW IMPLEMENTATIONS, AND RENEWAL ACTIVITY.

• REVIEWED, ANALYZED, AND VERIFIED THE INTENT OF ASSIGNED BENEFIT SET-UPS AS THEY RELATE TO PRODUCTS AND PROGRAMS.

• IDENTIFIED AND COMMUNICATED THE NEED FOR CUSTOMIZATION TO SUPPORT CLIENT BENEFIT REQUIREMENTS; ATTENDED CLIENT CALLS/MEETINGS AS NEEDED; ATTENDED INTERNAL VALIDATION MEETINGS; RAN CUSTOMIZED AND SCHEDULED REPORTS, MANAGE PERFORMANCE GUARANTEE TRACKING AND REPORT DISTRIBUTION FOR INTERNAL/EXTERNAL CLIENTS AS REQUESTED.

ALLERGAN, INC. MADISON, NJ JANUARY 2015 TO MARCH 2016 DRUG SAFETY SPECIALIST

• RESPONSIBLE FOR CASE RECEIPT, TRIAGE, CASE PROCESSING, AND REGULATORY REPORTING OF US AND FOREIGN SERIOUS AND NON-SERIOUS POST-MARKETING ICSRS IN ARISG AND ARGUS.

• ROUTINELY PERFORMED MEDDRA CODING OF ADVERSE EVENTS, DRUG INDICATIONS, PATIENT MEDICAL HISTORY, AND LABORATORY RESULTS.

• MAINTAINED COMPLIANCE OF SOURCE DOCUMENTS RECEIVED IN ACCORDANCE WITH FDA REGULATIONS.

• MONITORED AND RECONCILED RIGHT FAX UTILITY, GPV-US MAILBOX, CONSUMER CARE MAILBOX, AND INCOMING MAIL, UPLOADED TO DOCUMENTUM.

• VENDOR OVERSIGHT PERFORMING PV SAFETY ACTIVITIES: CASE PROCESSING QUALITY REVIEW (E.G., SCREEN CASES FOR ANY MISSED AESIS AND ENSURE MEDICAL CASE NARRATIVES WERE UPDATED ACCURATELY TO REFLECT ALL FOLLOW-UP INFORMATION, INCORRECT PSUR LISTENERS ASSESSMENTS) ON US AND FOREIGN POST-MARKETING ICSRS AND CLINICAL TRIAL CASES (SAE/SUSAR) ENTERED ARISG AND ARGUS, DETERMINE WHETHER CASES REQUIRE SIGNIFICANT CORRECTION AND REDISTRIBUTION/SUBMISSION TO HEALTH AUTHORS OR BUSINESS PARTNERS.

EXPRESS SCRIPTS FRANKLIN LAKES, NJ OCTOBER 2013 TO APRIL 2014 CLINICAL PRODUCT ENROLLMENT

• PERFORMED DATA EXTRACTIONS OF SPECIFIC THERAPEUTIC DRUG COVERAGES AND ENSURED PROPER DOCUMENTATION OF PRIOR AUTHORIZATION AND FORMULARY UPDATES AS PER CLIENT REQUIREMENTS TO ENSURE 100% ACCURACY OF OTHER PHARMACY BENEFIT CHANGES.

• USED INTERNAL SOFTWARE SUCH AS CLINICAL RULE STATION (CRS) AND CDP-ATK TO LINK PROGRAMS AND RELATED COVERAGE REVIEW CRITERIA FOR DAILY UPDATES.

• EXPERIENCED IN MICROSOFT SQL FOR COMPILING LARGE DATA FROM CRS FOR QC PURPOSES OR TO BE SENT TO CLIENTS

Skills

HARVEST, CELL THERAPY, BIOPHARMACEUTICALS, CLEAN ROOM, CLINICAL RESEARCH, GMP, GCP, ISO 8, ISO 7, LABORATORY SKILLS, MANUFACTURING PROCESSES, CGMP MANUFACTURING, VENIPUNCTURE DRAW, CAPILLARY DRAW. PEDIACTRIC BLOOD DRAW.

Education

HIGH SCHOOL DIPLOMA PASSAIC HIGH SCHOOL

ASSOCIATE IN EXERCISE SCIENCE PASSAIC COUNTY COMMUNITY COLLEGE 2026

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