SUSHMA CHOUDARY POTHINA

Work History

Sr. Associate Quality Scientist- Data Reviewer

Millipore sigma

04.2022 - Current

Responsible for cGMP analytical data review and paperwork generated during laboratory analysis in quality control division
Data review of routine final product analysis, in-process tests, raw material analysis, method validation/qualification, cleaning, environmental monitoring and or other data generated to support quality control activities at two sites
Review of data includes techniques like HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments
Responsible for data review of protocols and standard operating procedures as well as technical reports
Perform analytical data review of cGMP data in support of quality control group to ensure accuracy and quality of data
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Exercise judgment within generally defined procedures and practices
Solve problems and make decisions with assistance
Meet with internal project groups to keep projects on track
Maintain data review turnaround times and additional timelines with minimal oversight
Support review of OOS and OOT investigations, deviations, change controls and CAPA’ s
Apply problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor
Write and revise SOPs including raw material, intermediate, and final product specifications
Work cooperatively within QC department and with other departments to achieve project goals
Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
Support all data integrity initiatives and strive for right first time
Work in safe manner and maintain cleanliness of work environment.
Gained extensive knowledge in data entry, analysis and reporting
Acted as team leader in group projects, delegating tasks and providing feedback
Worked flexible hours across night, weekend and holiday shifts

Pharmacy Technician

Genoa Healthcare

07.2019 - 01.2023

Coordinated verification and filling of more than 150 daily prescriptions in high-volume retail pharmacy environment and ran package machine to organize medications as per time and date.
Answered incoming phone calls and addressed questions from customers and healthcare providers.
Communicated with patients to collect information about prescriptions and medical conditions or arrange consultations with pharmacists.
Counted, measured and compounded medications following standard procedures.
Performed various pharmacy operational activities with strong commitment to accuracy, efficiency, and service quality.
Solved customer problems in-person or over telephone by providing assistance with placing orders, navigating systems, and locating items.
Counseled customers on medications, appropriate dosage and potential side effects.
Coordinated with physicians and insurance agency representatives for speedy resolution of prescription discrepancies.
Resolved third-party billing, computer system and customer service issues.
Managed opening and closing duties for pharmacy.
Welcomed customers to pharmacy and answered questions relating to prescriptions and over-the-counter products.
Restocked pharmacy shelves with current merchandise to drive consistent peripheral sales.
Consulted with insurance company representatives to complete claims processing, resolve concerns, and reconcile payments.

Sr. Associate Production Scientist

Millipore sigma

07.2021 - 04.2022

worked as project lead and a part of hiring team and proved ability to work collaboratively and effectively.
conducted stand-up meetings to discuss daily-tasks and issues and how to resolve conflicts
Supported review of OOS investigations, deviations, change controls and CAPS’ s
Worked Cooperatively with QC and other departments to achieve project goals
Worked in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 where applicable
Utilized techniques for review such as HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD, among other tests and instruments
Worked in accordance with FDA, OSHA, EPA, DNR and DOT, and other regulatory agencies
Worked with EHS to assure guidelines are followed
Performed 5s and 6s audits
Learned and adapted quickly to new technology and software applications
Completed paperwork, recognizing discrepancies and promptly addressing for resolution
Passionate about learning and committed to continual improvement
Identified issues, analyzed information and provided solutions to problems

HEDIS Medical Record Reviewer

SSM healthcare

01.2021 - 05.2021

Conduct medial record abstraction, locate, and review all assigned medical charts, copy all supporting documentation per specifications and enter data into QSHR
Communicate effectively and professionally with care provider offices, clinics, hospitals, and other clinical facilities
Data entry, EMR abstraction, worked with EPIC, CERNER, and MEDITECH
Abide by all HIPAA and associated patient confidentiality requirements
Audit validation for reviewed chases to ensure quality of data entered
Co-ordinate and organize prepping and scanning of client documents as project is assigned
Paid attention to detail while completing assignments
Demonstrated creativity and resourcefulness through development of innovative solutions
Delivered services to customer locations within specific timeframes
Managed over 50 phone calls per day to collect data from client locations to provide data accurately and in timely manner

Pharmacy Associate

Government General Hospital

05.2015 - 04.2017

Provided specialized clinical services to help patient conditions such as diabetes, asthma, smoking cessation, HTN, properly compounded and dispensed medication as prescribed by physicians
Provided drug information to physicians
Recommended OTC therapies and counseled retail pharmacy patients
Collaborated with physicians to evaluate and improve patient drug therapies
Utilized pharmacist management software to review medication profiles to assure that prescribed medications are compatible with medications patient is currently taking
Accurate documentation of adverse effects to pharmacovigilance center
Preparation of SUA summary: analysis of similar events
Maintained good working knowledge of AE safety profile of assigned products and labeling documents
Follow up with patients as well as healthcare providers to provide clean picture of side effects
Project management & lead DSA assignment.

Clinical Research Intern

NRI General Hospital

11.2012 - 05.2015

Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
Performed informed consent process following FDA GCP guidelines
Prepared lab kits and do documentation for scheduled appointments
Ensure compliance with SOP’ s, FDA, ICH and GCP regulations for clinical conduct in all aspects of daily work
Assisted in survey development, response tracking, data requests, prepared study materials and ensure protocol adherence
Assisted in submissions and notifications to ethical committees and regulatory authorities
Meeting with site-monitors to ensure all source documentation and e-CRF are in protocol compliance & to ensure research data quality
Leads safety strategy for multiple or complex periodic regulatory documents (PBRER’ s, PSUR’ s, DSUR ’s) according to agreed process and timelines
Provided safety content review of clinical protocols, CSR’ s and ICF’ s
Developed questionnaire for research project
In-depth knowledge of ICH safety reporting regulations, GCP and other guidelines
Performed data entry of adverse events into share point data base ensuring cases are complete and consistent within timeframe.
Maintained accurate and up-to-date case report forms and source documents for traceability
Collaborated with physicians and other healthcare professionals to evaluate the effectiveness of treatments and diagnostic techniques

Clinical Laboratory Associate

CIPS

11.2010 - 03.2013

Worked on processing and cataloging blood samples
Provided technical support, maintenance, and calibration for centrifuges, scales and microscopes
Prepared selective broths and agar read and recorded plate counts, gram staining and identification for quantity analysis
Worked with pathogenic and nonpathogenic organisms in challenge studies using aseptic technique
Handled and properly disposed of autoclave hazardous waste
Responsible for cell culturing: cell growth and maintenance as well as taught new students about various culturing techniques
Performed analytical test using standard analytical instruments (HPLC, GC, NMR, ELISA)
Evaluated quality control within laboratory using standard laboratory test and measurement controls, and maintained compliance with CLIA, OSHA, safety, and risk management guidelines
Paid attention to detail while completing assignments

Summary

Overview

Work History

Sr. Associate Quality Scientist- Data Reviewer

Pharmacy Technician

Sr. Associate Production Scientist

HEDIS Medical Record Reviewer

Pharmacy Associate

Clinical Research Intern

Clinical Laboratory Associate

Education

Doctor of Pharmacy (Pharm D) -

Skills

Timeline

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