Jinal Patel
Lowell,MA
Summary
Experienced Quality Assurance, Document control specialist with a demonstrated history of working in Biotechnology industry, solid understanding of cGmP guidelines and ISO requirements. Skilled in change control system, ERP, End-user support, troubleshooting, Internal audit, Supplier audit, along with good leadership skills; strong attention to detail and an ability to manage multiple priorities.
Overview
10
10
years of professional experience
Work History
Quality Documentation Specialist I
Covaris
03.2021 - 08.2022
- Responsible for DCO review and tracking documents in change system
- Resolve deficiencies, inconsistencies and discrepancies in documentation identified for change and reviews change documentation for completeness and accuracy, including all aspects of Document Change Order (DCO) process
- Responsible for data entry for new part numbers, part revisions and bills of material into ERP system
- Ensures all Quality System records are controlled in a manner which ensures integrity and accessibility including photocopying/scanning of documents, as applicable
- Routing and releasing of controlled documents to ensure internal satisfaction and conformance to company requirements
- Creates and maintains new documents with input from Quality Assurance, Manufacturing, Engineering, and Marketing
- Archival of controlled documents
- Issuance of controlled documents
- Maintain electronic DCO Distribution logs
- Operate production equipment to produce labels, manuals, and software
- Sharepoint
- Lotus Notes
Engineering Document Coordinator
Jabil Healthcare
03.2020 - 02.2021
- Assist in creation of new procedures, work instructions, quality plans, and other documents using relevant Quality Management System (QMS)
- Prepare and review documentation which include: good manufacturing practice (GMP); procedures manuals; quality control manuals; engineering documents; manufacturing documents; manufacturing instructions; safety documents; and change authorizations in accordance with company policy and relevant government regulations and requirements
- Maintain CCNs (Change control notification) and EROs (Engineering release order)
- Advanced problem solving
- Excellent
- Maintain file for SOPs, ISO and other controlled documents
- Timeline management
- Excellent
- Project planning and development
- Excellent
- Project estimation and bidding
- Excellent
- Assist with the verification, approval, and processing of document revisions and track document activity to ensure timeliness and process efficiency
- Ensure new documents and records are consistent with company procedures, reviewing all documentation for accuracy, completeness and consistency in content, format, files and approvals
- Liaise with other departments to ensure proper documentation flow
- Work with subject matter experts (SMEs) to document impact Assessments for potential changes to mold, mold presses and assembly equipment
- Assist in creation, implementation, maintenance, change and distribution of training requirements; procedures; work instructions; and process binders.
Senior Project Developer
Nielsen
05.2016 - 10.2018
- Handled: Procter & Gamble, Reckitt Benckiser, ITC
- Geographies dealt ASEAN Countries (Indonesia, Malaysia, Vietnam, Thailand, Philippines, Singapore)
- Questionnaire Drafting: Understanding client's key objectives for conducting a study & drafting a questionnaire to suit the study objectives
- Have worked on various BASES services like new product concept testing, new product concept & product testing, price testing
- Helping them with regional inputs and understanding regional consumers
- Coordinating with multiple teams: Ensuring that the study runs smooth on field and solving issues at field level, while ensuring that the client and internal finance, Data analysis, Data tabulation, Data coding teams are updated about the project status
- Training new employees on SOP and ISO procedures
- Have also been part of external ISO audit
- Costing and Negotiating: Working on cost analysis and negotiating with the client for new projects
- Making sure that project budget is within the set benchmark.
Project Management Executive
Kantar Millward Brown
05.2012 - 05.2016
- Served as corporate liaison for IT, clients and marketing departments
- Reviewing questionnaire, proof-reading programmed script, troubleshooting errors before the project is live
- Creating field materials as needed and review concept stimuli
- Monitoring projects on daily basis to meet desired quotas within timelines
- Proactively updating client about status of project on regular basis
- Liaison with finance regarding to billing schedule and team's revenue forecasting and recognition
- Conduct training for new hires for ISO
- Affectiva and Eye Tracking champ for south Asia (Training, Troubleshooting, generating reports and providing access to new hires globally)
- Oversaw automated tracking and documentation of data, client correspondence and office operations
- Increased profitability and productivity by minimizing downtime and streamlining quality control procedures
- Produced high-quality documents, spreadsheets and presentations for internal and customer-facing needs using JIRA.
Education
Master of Science - Marketing Management
Mumbai University
2017
Bachelor of Science - Advertising, Business
Mumbai University
2012
Skills
- MS-Office suite
- Salesforce (eQMS)
- Arena (eQMS)
- Lotus Notes (eQMS)
- Great plains (ERP)
Accomplishments
- South Asia Role Model Award 2016 (Pricing-Project Management)
- South Asia Role Model Award 2017 (Growing Existing Client)
- Extra ordinary team member 2018
Additional Information
- Mumbai University , Accomplishments 2016- South Asia role model Award (Pricing – Project Management) 2017- South Asia role model Award (Growing existing client) 2018- You are a Star | Extraordinary Team member .
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Marathi
Native or Bilingual
Gujarati
Native or Bilingual
Timeline
Quality Documentation Specialist I
Covaris
03.2021 - 08.2022
Engineering Document Coordinator
Jabil Healthcare
03.2020 - 02.2021
Senior Project Developer
Nielsen
05.2016 - 10.2018
Project Management Executive
Kantar Millward Brown
05.2012 - 05.2016
Master of Science - Marketing Management
Mumbai University
Bachelor of Science - Advertising, Business
Mumbai University
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