Information Management Clinical Documentation
Resume:
FARIDA SAVAI: Oakland CA
**********@*****.***
PROFESSIONAL SUMMARY
I have 23 years of experience and knowledge in monitoring and managing patients; 15 year of experience in Life Science working in laboratory (LMIS) with DNA extraction, develop micro assays and genome testing, and 15 plus year of FDA regulatory experience, and proficient in healthcare information management and Laboratory Managements System.
SKILLS
Knowledge of electronic health record like Cerner and Epic, BIOMES, Delta V
Data Analysis, Clinical documentation ALCOA+
Genome Sequencing: BLAST, PERLA
Mammalian cell culture and Proficient in pathology-based methodologies, AAV gene therapy
Knowledge of ICD 9-10 and HCPS Coding
Computational Biology
Schuylab—Laboratory Information Management Software
Gel Electrophoresis/Western Blot
Minitab – statistical software and SPSS
Immunochemistry, ELISA and PCR assays
ISO standards and FDA/QSR
HIPPA
Microsoft Office and Outlook
Patients’ diagnosis and treatment
Knowledge in Python and R
Typing speed 35 wpm.
Experience in clinical documentation and xGXPs:
In vitro human salivary cell assays
Documentation Review and Management as per Regulatory Affairs
Clinical Trials
FDA regulations and compliance
UCSC genome browser for Next generation sequencing
Proficient in using LIMS, Cerner and Epic, PACS
Dose administration: IV, IM, PO, slow infusion and intra spinous
EDUCATION
University of California, San Diego La Jolla
Master’s in Clinical Research (1 year completed) 2009
M.G.M. Medical College, New-Mumbai- India 2002
Bachelor of Medicine and Surgery with Clinical rotations and internship
Mira Costa College, Oceanside- CA 2014
Associates of Science in Research and Development in Biotechnology
Laboratory Skills in Biotechnology 2012
Cal State University San Marcos, San Marcos- CA 2015
Healthcare Information Technology Certificate
University of California San Diego, La Jolla- CA
Professional Certificate in Regulatory Affairs for the Biomedical Industry 2012
Specialized Certificate in Clinical Trial Administration Program 2010
Palomar College, San Marcos- CA
Medical Office Specialist Certificate 2015
More Certifications……
Wockhardt Hospitals –Mumbai-India 2006
HIV/AIDS Basic and Advanced Training Program for Health Care Provider
Basic and Advanced Life Support Training -4 days
Needle Stick Injury –Hazards and Prevention
Government of Gujarat Health and Family Welfare Department 2004
Medical Officer training in Revised National Tuberculosis Control Program
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Rehabilitation Council of India – 2004
National Program on Orientation of Medical Officers on Disability Management
Scientist
Boehringer Ingelheim Fremont, CA Jan 22 to Current
Executed, overseen, supported routine unit operations in Cell Culture /Purification such as bioreactor inoculation, cell separation, chromatography and tangential flow filtration using aseptic techniques, as well as Clean-In-Place (CIP) and Steam-In-Place (SIP) operations using Delta V and BioMES. Practiced ergonomic safety and used appropriate personal protective equipment (PPE) in all operations
· Performed in-process analytical instrument measurements of e.g., pH, cell viability and viable cell density, osmolality, gas content, metabolites, spectrophotometry, or conductivity and flow cytometry.
Documented execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP), Good Manufacturing Practices (GMP)
. Responsible for ensuring protein/cell samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics for various test.
Performed internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents,
recognizing, and reporting process and equipment anomalies
Reported any issues related to manufacturing performance, process and safety to the team lead or Manager to ensure safety and compliance with
regulations and cGMPs and to facilitate continuous process improvement.
Adhered to GMP training schedule and responsible for achieving all training requirements within acceptable timelines
Performed routine housekeeping of the manufacturing plant using the 5S organization methodology by using a appropriate equipment safety signage, labeling of parts-in-process, sweeping water pools to the floor drain, and picking up parts from the floor
Unit operations described in standard operating procedures and batch records
Recognized, advised and corrected errors in bioprocess operations prior to failure
Recommended and executed projects and changes to bioprocess operations to reduce risk and increase efficiency
Performed review of GMP documentation for accurate data analysis.
Completed required processing documentation including, product change over and other documentation
Reviewed, signed and executed processes and solutions using MBRs
Ensured acceptable quality and quantity of work executed
Ensured that standard operating procedures (SOPs) are followed and are correct for bioprocess operations and equipment
Ensured Life Science regulatory compliance with company quality systems, safety procedures, and other company policies
Used judgment to apply industry practices and company policies to daily operations
Clinical Document Improvement Consultant June2021-Aug2021
Kaiser Permanente, Oakland, CA
In Epic, reviewed 70-150 inpatient and outpatient encounters from Medical Records contained in the organization’s electronic health records (EHR).
Overseen, data mined/extraction 10-15 clinical and laboratory findings for diagnosis per patient that have potential for clinical documentation improvement due to presence of clinical indicators and performed required data analysis as per regulations in Good Clinical Practice.
Chronic Kidney disease, Diabetes Mellitus, Hypertension, Atherosclerosis of Aorta, Major Depressive Disorder (MDD) conditions found are reported and collaborated to and with Quality Assurance and Providers through verbal and written communication for educational purposes.
Research Assistant
Life Chiropractic College West, Hayward, CA May2018-June2021
Performed various research support activities, research applications (e.g. EndNote, QualTrics), and data support (both general purpose and project specific)
Screened and interviewed study participant for the Service Trip America and Alternate Science Programs
Managed project meetings and conference calls with vendors, and multifunctional teams involved in quantitative clinical study/trials
Followed all clinical and regulatory compliance affairs.
Supported the submission of research papers for publishings.
Casualty Medical Officer July2017-Feb2018
B.D. Parsee General Hospital- Cumballa Hill- Mumbai-India
Supported and executed ordering and interpreting 20 tests for patients.
Analyzed 20-25 records, reports and exam data to help them diagnose patients’ conditions.
If further information is needed, they will order additional tests, consult with other physicians in the field or the patient’s previous healthcare professionals.
Oversaw the medical care of 70-100 patients and the functions performed by medical staff.
Maintained 100 patients accurate Documentation.
Dedicated to patient safety and quality of healthcare.
Lead standardization of care…
Research and Development Associate Sept 2016– December2016
GenMarkdx –Carlsbad, CA
Followed cGMP and ISO standard guidelines as they applied to manufacturing using sterile aseptic techniques
Prepared formulated and labeled two Depos for ELISA, one PCR mix for mammalian cells, Single Buffer each by following Standard Operating Procedures and guidelines given by his or her supervisor
Everyday followed good documentation practices to comply with ISO standards and FDA/QSR requirements
Organized and controlled four to five batch production records
Recommended revision of procedures and specifications to batch records
Collaborated with Rand D in development of in vitro mammalian cell based micro assays for the viral and bacterial respiratory infections.
Strong knowledge in basic pharmacology, drug metabolism (characterizing and identifying metabolite) and in PKPD relationship.
Laboratory Technician December2012–August2013
Auto Genomics. Inc., Vista, CA
Generated 212 DNA extractions per day and PCR testing using human and mammalian cells. Also, processed 500 patient reports for personalized DNA profiling and data analysis.
Efficiently managed quality control documents for Food and Drug Administration compliance and assisted in developing laboratory management information system for accurate reporting and billing.
Trained and supervised 5 lab technicians to prioritize lab testing, reporting, and use lab management information system.
Overseen, supported and executed in the development of micro assays for personalized medicine for DNA genetic profile eg: Hepatitis
Assisted and coordinated with tech support to fix errors in calibration of instruments in aseptic sterile conditions
Performed scientific and technical procedures: e.g., test substance formulation, dose administration, cell culture, cell biochemistry, have significant experience and expertise using ELISAs, Flow Cytometry.
Research and Quality Control Scientist Sept- October2012
Alere, San Diego- CA
Collected, analyzed and evaluated 80-160 blood and plasma of mammalian and human sample.
Prepared audits on Good Manufacturing Practices
Maintained and 4-6 calibrated test equipment using standardized devices.
Followed protocol to develop micro assays for measuring the toxic effects of drugs on cardiac and liver.
Performed scientific and technical procedures: e.g., test substance formulation, dose administration, cell culture, cell biochemistry, significant experience and expertise using ELISAs, Flow Cytometry.
Sample scanning for pathologist review or quantitative image analysis.
Manage sample tracking and communicate updates and instructions to downstream team members
Work closely with scientist to communicate project status, QC data, and generate reports.
Compile quantitative image analysis data and prepare standardized pathology reports.
Maintain standardization of histology sample collection, processing, storage, and analysis.
Coordinate with external partners to ensure all related work and data generation is in alignment with internal methods an
Laboratory Intern-Part-Time May -August 2012
Assure Control, Vista- CA
Completed 3 basic laboratory standard operating procedures for day-to-day preparations and observations.
Recorded and data analyzed the results of cell culture and their water toxicity. Also, prepared cell culture in saline water, plankton, as well as feeding and harvesting it. Used flow multicolored cytometry for analysis cell viability.
Processed all documentation of cell culture testing results in Excel daily
Laboratory Technician
Mira Costa College, Oceanside- CA March 2010-May2016
Assisted setting up Biochemistry lab experiments for student lab work
Prepared 20 buffers and solutions.
Managed organic and inorganic wastes.
Ran two-three tests and recorded results for data analysis.
Followed standard operating procedures for cleaning glassware and instruments.
Used mini bioreactor technology which allows for high throughput process development for both cell culture process and microbial fermentation (partnership between Mira Costa College and Genentech)
Used UCSC genome browser for mapping and sequencing
Resident Medical Officer
>Wockhardt Hospital, Mulund- Mumbai, India 2005-2007
>Civil Hospital, Ahwa-Gujrat, India 2004-2005
>Manisha Hospital-Malad-Mumbai, India 2002-2004
Provided leadership, overseen, executed the medical care of 100-150 patients per day and the duties performed by medical staff.
Maintained 200 patients’ accurate documentation per day.
Dedicated to patient safety and quality of healthcare.
Responded to patients’ medical issues by starting with their history.
Ordered radiology and laboratory tests and refer patients to specialists when necessary.
Analyzed 80-90 per day reports, examinations, and test results to accurately diagnose patients, as well as present treatment options
Discussed and explained treatments and medication thoroughly with patients, advising them of all the side effects and making sure that all allergy information is current before prescribing any medication or treatment.
Administered medications doses through intravenous (IV), Subcutaneous, intramuscular (IM), Per Oral, intra spinous and slow infusion as prescribed
Collected blood and urine for analysis.
Collected specific organ tissues for biopsy, culture, and pathology diagnoses.
Performed swabbing of wounds and throat to diagnose bacterial growth.
Advised patients on lifestyle and diet changes that could help improve their health or treat the health problem they have
Followed all departmental policies and procedures.
Maintained date with medical procedures, developments, treatments and available medication.
Complied with hospital privacy laws, always respecting a patient’s confidentiality.
Proficient in pathology-based methodologies including IHC, multiplex IHC, immunofluorescence imaging and other advanced microscopy, digital pathology/image analysis, specialized tissue sectioning and histology procedures.
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