Charu Singh
Quality Control Documentation Specialist • QC-GMP at Cambridge Isotope Laboratories, Inc- Claim this Profile
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Bio
Experience
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Cambridge Isotope Laboratories, Inc
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United States
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Chemical Manufacturing
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100 - 200 Employee
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Quality Control Documentation Specialist • QC-GMP
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Apr 2023 - Present
Andover, Massachusetts, United States
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Takeda
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Japan
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Pharmaceutical Manufacturing
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700 & Above Employee
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QA Specialist l
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May 2021 - Oct 2022
•Prepare and execute plans to address the compliance gaps that are a consequence of the shutdown of the Orth facility and/or the integration of Legacy programs, which supported cell bank stability testing. • Prevent new compliance gaps that may occur for Cell bank stability with the divestment of the Hayward site and integration of Shire and Takeda. • Prepare stability protocols, generate overdue reports, collect data from manufacturing sites, initiate stability testing, see… Show more •Prepare and execute plans to address the compliance gaps that are a consequence of the shutdown of the Orth facility and/or the integration of Legacy programs, which supported cell bank stability testing. • Prevent new compliance gaps that may occur for Cell bank stability with the divestment of the Hayward site and integration of Shire and Takeda. • Prepare stability protocols, generate overdue reports, collect data from manufacturing sites, initiate stability testing, see stability studies through completion and manage quality systems associated with cell banks stability topics. • Oversee the release testing of cell banks. • Supporting stability activities, document revisions, quality documentation, deviations, and/or investigations Show less
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LSNE Contract Manufacturing
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Document Control Coordinator
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Feb 2021 - May 2021
• Write and review SOPs and processing documents • Batch record review • Quality records review • Creating and revising documents using MS Office • Maintain living documents files • Issuing controlled documents and form • Writing CAPA and Deviation reports • Line Clearance assistance • Perform internal audits • Perform monthly verification checks of equipment accuracy • Make new revisions effective, assign and distribute training, obsolete old revision
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East Boston Savings Bank
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United States
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Banking
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100 - 200 Employee
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Relationship Banker
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Aug 2019 - Oct 2020
•Meet quarterly quota objectives for field sales meetings •Provides account services to customers by receiving deposits and loan payments, cashing checks, issuing savings withdrawals, and recording night and mail deposits. •Demonstrate good risk management decisions, including displaying solid knowledge of guidelines for fraud prevention and robbery •Work with branch team to think of new sales strategy. •Promote training events for ELAN (credit).
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Moderna
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United States
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Biotechnology Research
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700 & Above Employee
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Manufacturing Associate
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Oct 2018 - Sep 2019
• Aware of and adhere to GMP standards. •Collate data report, data sheet, and/or database from paper-based and electronic sources • Assist in updating standard operating procedures and manufacturing documents. • Keep up to date employee EHS handouts in all specified areas. • Set up one-on-one meetings with operators and managers. • Book conference rooms for monthly/weekly meetings to go over production. • Upload FA data and ensure product decisions are made… Show more • Aware of and adhere to GMP standards. •Collate data report, data sheet, and/or database from paper-based and electronic sources • Assist in updating standard operating procedures and manufacturing documents. • Keep up to date employee EHS handouts in all specified areas. • Set up one-on-one meetings with operators and managers. • Book conference rooms for monthly/weekly meetings to go over production. • Upload FA data and ensure product decisions are made appropriately. • Keep track of Veeva Documents and revise any older documents to adhere to current practices. • Follow up with manufacturing and research department in regards to outstanding SOPs. Show less
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Entegris
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United States
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Semiconductor Manufacturing
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700 & Above Employee
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Research And Development Technician
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Oct 2017 - Oct 2018
billerica,MA • Run gravimetric nonvolatile residue analysis via Rocket Evaporation. • Liquid sample prep for GC-MS and ICP-MS. • Documentation safety reviews, pilot/scale-up sample records, work instructions, standard operating procedures, specifications. • Maintain, clean, and sterilize laboratory instruments and equipment. • Ashing membranes for metal analysis. • Liquid-Liquid Extractions . • Familiar with basic GC-MS data analysis. • Run standard and routine GC-MS… Show more • Run gravimetric nonvolatile residue analysis via Rocket Evaporation. • Liquid sample prep for GC-MS and ICP-MS. • Documentation safety reviews, pilot/scale-up sample records, work instructions, standard operating procedures, specifications. • Maintain, clean, and sterilize laboratory instruments and equipment. • Ashing membranes for metal analysis. • Liquid-Liquid Extractions . • Familiar with basic GC-MS data analysis. • Run standard and routine GC-MS samples. • Maintain and update lab inventory. Show less
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Winchester Hospital
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United States
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Hospitals and Health Care
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700 & Above Employee
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Patient Registrar
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Oct 2015 - Feb 2018
Winchester,MA Patient Registrar Tasks -Assess method of payment for services -Greet visitors, ascertain purpose of visit, and direct them to appropriate department -Perform admitting duties including explaining various forms such as patient rights, medical releases and insurance
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Designer Perfumes
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United States
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IT Services and IT Consulting
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Manager
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Sep 2012 - Nov 2015
Saugus,MA -Tracking Budget Expenses -Vendor Relationships -Market Knowledge -Results Driven -Strategic Planning -Management Proficiency -Client Relationships -Verbal Communication
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Education
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Lasell University
Master's degree, Business Administration and Management, General -
Salem State University
Bachelor's degree, Biochemistry