Arpi Sheth
Summary
Document Processing Specialist developing and implementing document control and management strategies. Stores documents correctly for easy employee access. Excellent communication and organizational skills, with proficiency in standard office software and attention to detail.
Overview
5
5
years of professional experience
Work History
Quality Assurance documentation specialist
Legend Biotech
08.2022 - Current
- Issuance of batch related documentation and labels in support of GMP manufacturing.
- Reviews and approves GMP documentations and cGMPs documentations, work order requests, and return-to-archive documentation.
- reviews SOPs, policies to ensure compliance and obedience to regulations/cGMP operations.
- Creation and issuance of cGMP logbooks/formbooks/notebook.
- Support internal audits.
- organized revisions and tracked changes.
- Perform tasks in a manner consistent with the safety policies,quality systems and cGMP requirements.
- Provided assistance with inbound and outbound document processes, document sorting, logging and work order creation.
- Identified areas of weakness and recommended or implemented process improvements.
Tissue Manufacturing Operator
Cellularity Inc
10.2021 - 06.2022
- Aseptic manufacturers cell therapy products
- Operates in classified manufacturing environments and clean room suites
- Prepare and maintains cell culture reagents and media
- Participates in process development, training activities and technical process transfers for existing and future products
- Performs various clean room suits and techniques on time sensitive material with accurate and precise manipulation
- Restructured products and logistics systems
- Adheres to good documentation practices when executing and completing batch records and electronic data entries
- Adheres to good molecular bio skills.
Lab technician
Quest Diagnostics
09.2021 - 10.2021
- Under general supervision and according to policies and procedures, perform routine activities involved in the preparation of histopathology slides
- Receive/collect, label and prepare tissue specimens for gross dissection
- Process paperwork associated with accessioning and reporting
- Monitor inventory, requisition supplies prior to depletion, stock and maintain laboratory supplies
- Operate, clean, and sterilize laboratory equipment, glassware, and instruments
- Maintain a clean workstation in the grossing area
- 6
- Perform cover slipping of stained slides either manually or automated
- Process covid 19 samples with the method of RT-PCR
- Responsible for all assigned clerical duties associated with the Histology laboratory
- Maintain confidentiality of sensitive information concerning patients, physicians, employees, clients, vendors, and the company
- Ensure all corporate safety, quality control and quality assurance standards are met
- Maintain a clean and well-organized work area
- Good practice working in the molecular department.
Lab Technician
divine Lab
08.2018 - 03.2021
- Support the laboratory in maintaining an efficient workflow by assisting laboratory personnel
- Perform laboratory tests like hematology,urinalysis, biochemistry, microbiology,coagulation and blood and urine culture
- Prepare samples/specimens
- Sample collection/specimen
- Perform daily quality control checks
- Prepare reports with reliable data
- Interpret results based on findings
- Use latest methodologies and best practices
- Adhere to correct procedures and policies
- Maintain and track results
- Maintain cleanliness, orderliness, and supplies
- Help with administrative tasks when needed
Education
Diploma - Multi Lab Technician
Teamlease Skills University
2018
Bachelors of Science -
Sardar Patel University
2017
Skills
- DNA extraction
- RT-PCR(reverse transcription polymerase chain reaction)
- ELISA
- Aseptic Technique
- GxP
- CGMP Manufacturing
- Microsoft Office
- Laboratory Skills
- Good Documentation Practice
- Clean Rooms
- FDA Compliance
Timeline
Quality Assurance documentation specialist
Legend Biotech
08.2022 - Current
Tissue Manufacturing Operator
Cellularity Inc
10.2021 - 06.2022
Lab technician
Quest Diagnostics
09.2021 - 10.2021
Lab Technician
divine Lab
08.2018 - 03.2021
Diploma - Multi Lab Technician
Teamlease Skills University
Bachelors of Science -
Sardar Patel University