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Documentation Specialist Tax Preparer

Location:
Iselin, NJ
Posted:
June 01, 2023

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Resume:

Shah Charulata J.

adxghl@r.postjobfree.com

732-***-****

SUMMARY:

Whether it is medical field or business field, I utilize my accuracy, precision, good communication skill for people that I possess and also to enhance them further.

Over twenty years of experience within the medical field enables me to work well in either the public or private industry. I have worked as Medical Technologist, Pharmacist, Quality Control Chemist, and Quality Assurance including regulatory affairs. My work experience has increased my knowledge in the medical field. I believe my background reflects a hard worker professional who feels highly capable of handling many technical details in the field of my work.

My past education background in the medical field, with high accomplishment and work ethics which earned me green card in USA, thru employment as QA from Pharma industry.

WORK EXPERIENCE:

Teva Pharmaceuticals Inc. Elizabeth NJ February 2023 – May 2023

Sr. Quality Auditor: Review and release of Batch Records in a compliant manner within the established timelines. Software Used: QAD, LIMS, Trackwise, Trackwise Harmonny – QMS system.

Pharmaceutical Innovations Inc. Newark, NJ March 2022 – November 2022

QA Specialist: Writing, revising, review of SOPs, Batch Records Review and Release, Daily monitoring GMP compliances, Maintained Retain Samples rooms for stability studies, Maintained data base for QA (electronic and Manual), Issued BPR, released BR’s, Printing Labels for shippers, issue of labels for packaging, reconciliations of labels. Proof read of labels. Review and approval of analysis reports/certificate of compliances for batches, stability studies, raw materials, and packaging component Implemented extensive changes to bring company with compliance with FDA and EPA. Assisted to retain the regulatory documents as per compliance from FDA and IRS regulations when CEO/Owners planned to windup company business.

Various Business Experiences (During sickness and unemployed period): January 2012- March 2022

Real Estate and Business: Sales and Evaluation techniques.

Income Tax Preparation: (CEO with Tax Mathematics – Prepared Taxes with Proseries tax software).

My accurate and detail oriented documentation skill that I possess, helped me to prepare accurate tax returns for the clients hence resolve their problems with IRS tax filing. Attended free live webinars and earned 160+ CE on CPA.org, Made myself familiarity and updated of current technology of cloud based software, share file etc. Attended live online FDA webinars for Regulatory Affairs for updating myself with industry.

Visited India (2016) and Canada (2015): For my sick relatives, but lost them hence involved in counseling of grief to my sibling as both of my siblings are left alone in Canada and India. Unfortunately, Lost 2 my brothers; 1 in Tennessee(3/2021) and 1 in Canada (4/2022).

Widely travelled across USA (every States except few), in search of business endeavors for myself; but obtained my valuable experience of various business audits, evaluations and its operation beside pleasure touring for enjoyable experience.

Beside these- Lot of time spend for local pharm QA job search but not much luck except 3-11/2022.

However, fortunate to recover myself from sickness which was occurring thru medication; by quitting all OTC allopathic supplements that was advised to me by my physician. Learn to cure my own body system by myself (based on my Pharmacist skill) with alternative medication than just follow doctor’s advice.

Worked myself as Tax preparer (per diem) Tax Mathematics; LLC Iselin NJ January 2017-18

Software: Proseies tax software

MTF (thru Kaztronix) Edison, NJ July 2016

QA Documentation Review: Reviews of Dermis Product for Release.

Hershey Realty/R&R office, Iselin NJ April 2014 – October 2015

Front Desk Part time: Greeting walking-in customers at the office, Answering Phone calls, Updating database for properties (Residential and commercial) showing, Preparing sales contract for Brokers and agents for their property’s sales, making appointments for properties showing for brokers and sales professionals, Call or text to atty. based on client’s needs, Maintained phone call books for attorneys and employees. Uploaded listing in MLS

Mr. Vieira Manuel’s CPA office, Union NJ February 2015-April 2015

Tax Preparer Part time: Software used - Lacerte tax software

Prepare taxes for clients.

Evonik Industries, (thru Aerotek) Piscataway, NJ October 2011- December 2011

Quality Specialist//Doc Specialist: Helping to resolve ISO inspection’ citations hence prevent future incidents for CAPA plan, Writing SOPs, Documentation Control, Establishment of QA systems, SOP Training and technical writing training to interns and employees which includes laboratory and manufacturing and R &D personnel, Warehouse personnel, Maintaining Databases for QA and sales in SAP.

Software: MS office, Outlook for interoffice communication

Sunrise Pharmaceuticals, Rahway, NJ February 2010 – March 2010

Quality Specialist: Writing SOPs, Revising SOPs, Designed Vendor audit program, Drafting Quality Agreements between Contract manufacturer and Sunrise Pharma. Established Documentation control system, Inventory controlled for RM, PC, and Labeling, Proofread Labels, Inserts / Outserts, In-house GMP audit for plants included manufacturing and packaging areas, Recommended descriptive changes in batch records documents for cleaning logs and line clearances, recommended corrective action for compliance of GMP with reference to temperature records, sanitization and for CAPA plan.

Software: MS office, Outlook for interoffice communication

Chromak Research Inc., (per diem) Somerset, NJ October 2008 – January 2010

QA/QC Chemist: Performed analysis of Pharmaceutical finished product and raw materials by USP, NF and in-house test methods using HPLC, GC, TLC, UV, IR and wet chemical techniques. Conducted dissolution of solid dosage forms. Calibrated and maintained laboratory equipments, ensured compliance with CGMP/CGLP and participated in troubleshooting and problem solving. CGMPs training, Writing SOPs, training on SOPs, Documentation controls for CAPA plan.

Austar Pharma, (thru Aerotek) Edison, NJ March 2006 – March 2007

QA Manager: Assistance to the President, Vice-President, and other technical and managerial personnel for establishing QA Systems, training for GMP, Establishing system for Document Control and GMP audit, which includes lab, R&D and Plant for new facility in USA, Writing and training on SOP’s for labs and GMPs, Deviation reports, Auditing and releasing clinical Batches for ANDA submission. Helped to get successful ANDA approval in less than year. Managed the deviation and investigation for contract manufacturing facility for Austar’s clinical batches, suggested changes for Batch documentation, for future incidents for CAPA plan. Software: MS office, Outlook for interoffice communication

Taro Pharmaceuticals, Cranbury, NJ April 2004 -July 2005

QA Release Auditor / Batch Record reviewer / QA Manager: Review Batch records for releasing the products in a timely and compliant manner within the established timelines, Inspections of Quarantined Finished products, Returned products, Sampling of products as and when needed. Writing Deviations and Investigations reports, CAPA, writing and training on SOPs, Creating forms for Inspections, Created Maintaining Data base for products –(Documents receipts, products receipts, FDA Releases, DEA Releases, Status of Batches etc.), Preparing weekly reports for the managements, Established system for Documents Control and GMP audits, run Labeling operations for finished products, Dealing with visitors and FDA during inspections and Investigations etc. Maintained inventory of controlled substances, trained warehouse personnel for GMP documents and their work.

Software Used: BPCS, WMS, Outlook for interoffice communication

NUTRAMED INC., Rahway, NJ October 2002-March 2004

Quality Assurance Manager: Assisted to the Quality Assurance staff and other technical and managerial personnel. Established QA Systems, trained to QA, Established system for Document Control and GMP audit, which includes lab, R&D and Plant, Reviewing the Validation protocols, Issue, review / audit / approval / release of batch records in a compliant manner within the established timelines. Writing SOP’s, Deviation reports, handling complaints from the customers & clients (identifying and verifying product quality issues associated with complaints and conducting and/or coordinating product investigations, recall of products. Responsible for entering all results into Regulatory Compliance Complaint Handling System), CRS (Consumer Response System), registration of Drug listing with FDA, DEA inventory reporting in ARCOS, Dealing with visitors for new biz order, FDA during plant inspection or investigation.

G & W Laboratories, Inc., South Plainfield, NJ June 1999-October 2002

Q.A. Auditor / Documentation Specialist: Duties included issue, review / audit / approval / release of batch records (electronics and Manual) in a compliant manner within the established timelines, Process Validation protocols, Batch release for shipping, and Maintained the database of BR’s and Annual Review of Products, Filing of BPR’s, MFBPR, Obsoleted MFBPR, CRA’s. Initiated CRA’s, Wrote SOP’s & provided assistance to management and company sales personnel, customers, beside quality assurance staffs and other technical personnel. Software Used: Manman System for batches released.

LINI INC., Rahway, NJ June1994-July1998

Quality Assurance Supervisor: As a supervisor I provided assistance to the Quality Assurance staff and other technical personnel. Approved and proofread labels & literatures. Also, performed duties such as Document Control, and GMP audit, which included lab, R&D and Plant, Issue, review / audit / approval / release of batch records in a compliant manner within the established timelines, Maintenance and retrieval of Samples as and when needed. Writing SOP’s, Deviation reports, handling complaints from customers & clients (identifying and verifying product quality issues associated with complaints and conducting and/or coordinating product investigations, recall of products. Enter all results into Regulatory Compliance Complaint Handling System), CRS (Consumer Response System), Registration of Drug listing with FDA, DEA inventory reporting in ARCOS, Dealing with visitors and FDA during plant inspection and investigation, etc.

GREENSVILLE MEMORIAL HOSPITAL, Richmond, VA 1993

Medical Technologist: Responsible for the analysis of body fluid i.e. Blood, CSF, and Urine

RICHMOND EYE & EAR HOSPITAL, Richmond VA 1991

Lab Technician: Responsible for the analysis of body fluid i.e. Blood, CSF, and Urine

EDUCATION:

P.V. Polytechnic, Santacruz, Bombay, India March 1980

Diploma in Pharmacy,

Registered Pharmacist with Maharastra State Pharmacy Council, Bombay, India

Ramnarayan Ruia College, Matunga Bombay, India May 1984

Certificate Course in postgraduate Diploma in Analytical Chemistry

Parle College, University of Bombay, India May 1986

B.S. in Microbiology, Chemistry as a subsidiary subject

Medical College of Virginia, VCU Richmond, Virginia May 1992

B.S. in Medical Technology,

Registered medical technologist by ASCP (1992-2021)and NCA- Board of registry

PROFESSIONAL ACTIVITIES:

Attended webinar Generic Drug Forum 2018; 12 credits pre-approved for RAC-recertification..

Associate member of ASCP since 1992-2021

Associate member of Indian Journal of Pharmaceutical Science, Bombay, India, 1980-85

Received the leadership award for “Bombay Municipal Pharmacist’s Association” 1983

Provided training to intern in pharmacy while working as shift supervisor, Bombay, India, ‘80-85

Completed XII-Science, B.Sc. (Microbiology), post graduate Analytical Chemistry Diploma and also holding 48hours/week employment as a pharmacist (1980-89) to achieve higher goal.

SKILLS:

Computer and Internet literate Bilingual Hindi-English

Works well independently and as team member Excellent clerical skills

REFERENCE: Available upon request.



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