QA Specialist

Kashka Bleach

EXPERIENCE

•Strong background related to independently managing day to day activities related to Document Control practices in both cGMP regulated and unregulated environments

•Oversaw all cGMP issues found in the batch record review process before archiving

•Tracked and trended deviations, change controls, temporary changes, CAPA and product complaints to closure

•Scanned and uploaded documents to the electronic filing Quality Management System

•Implemented new batch records, Logbooks, and SOPs

•Knowledge of using a quality management system (TrackWise, Master Control, Veeva Vault, CATSWeb, Compliance Wire, ilearn, Geode+/Gibraltar, Phenix)

•Worked in cross-functional teams to resolve issues quickly and effectively

•Continuous working knowledge of 21CFR820, 21CFR210/211, ISO 13485, ISO 9001 and additional applicable federal regulations such as HIPPA Compliance

EDUCATION

Roxbury Community College, Boston, MA

Bio-Manufacturing Certificate

WORK HISTORY

Vertex Pharmaceuticals - Boston, MA (6-month contract extended) September 2022 – September 2024

Quality Specialist

•Independently manages the full life cycle of the Document Control processes including QA Documents (SOPs, WIs, Forms, etc)

•Review and process Chemistry, Manufacturing, and Controls Documents (CMC) (Quality Standards, Analytical Methods, Specifications, Batch Records, etc.)

•Recognized as a technical resource within discipline; answering questions and requests related to the Document Management System (CMC, QA, System Downtime, etc) and incidents and

service requests

•Document Management System Business Owner responsibilities

•Conducts reviews of Quality and GxP SOPs, Work Instructions, forms and templates

•Proactively identifies opportunities for process improvements in the Document Control program and works cross functionally to implement

•Maintains user training materials for new users of the document control computer systems and business processes

•Interacts with internal and external customers and functional groups at various management levels to provide customer service

•Participate in regulatory inspections or due diligence activities, as requested

•Act as document control representative on internal and external cross functional projects driven sub-teams

Moderna - Norwood, MA September 2021 to March 2022

Principal Compliance Quality Associate II

•Closely partner with peers for disposition of Plasmid, Drug Substance and Drug Product

•Participate in quality focused teams across Moderna’s broad ecosystem of functions.

•Authors and reviews SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.

•Oversee and review executed electronic and paper batch record documentation.

•Develop/Revise batch records, SOPs and training materials

•Reviews manufacturing deviations.

•Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.

•Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.

•Monitor process operations to ensure compliance with specifications.

•Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.

•Utilize knowledge to improve operational efficiency.

•Participate in quality oversite of manufacturing through real-time observations of activities.

Sanofi - Framingham, MA (12-month contract) December 2020 to September 2021

Assurance Specialist/QA on the floor

•Perform all aspects of lot issuance, lot review and release process, ensuring compliance to the relevant site release SOP and corporate standard.

•Participate in investigation of all lot-associated deviations.

•Perform QA presence on the floor oversight and AQL inspections

•Ensure compliance to the relevant SOP and corporate standards.

•Perform various Quality Management System (QMS) trending/reporting functions.

•Perform and/or participate in monthly/weekly/daily compliance walkthroughs.

•Perform logbook/log sheets quality compliance reviews

•Final label and packaging product inspections

Sanofi, Cambridge, MA (6-month contract) Oct 2019 – March 2020

Quality Manager I

•Improved and decrease the CAPA backlog by 70%

•Track Events and CAPAs for workflow deadlines, updated status or extended due dates

•Contact document owners to assist them in closing Action Item

•Process CAPA, Events, and Change Control request within a validated system (i.e. Phenix,)

•Manage all assigned task in JIRA

•Act as Scrum Master for Bi-weekly Sprint meetings for Scrum Team

•Worked as a team member on cross functional problem solving

•Training on internal audits and FDA inspections readiness

•Support all quality needs in processing new versions of SOPs, Work Instructions within the eDMS (i.e. Master Control) and also Geode+/Gibraltar

•Connect with management of all levels to ensure work processes are being followed

Immunogen, Inc, Norwood, MA Oct 2018 - Feb 2019

Quality Assurance Document Specialist

•Served as an SME and Lead for documentation in the decommissioning project

•Oversaw all cGMP issues found in the batch record review process before archiving

•Scanned and uploaded documents to the electronic filing Quality Management System

•Updated Electronic Systems with information provided by other departments when requesting Documents

•Filed hardcopy records submitted to Quality Documentation for archiving

•Worked as a team member on cross functional improvements and problem solving

•Maintained the controlled supply of Master and Executable documents

•Organized, filed and retrieved all documents in the Regulatory and Clinical Archive rooms

•Worked with QAO to maintain and retrieve requested or required documentation and controlled documents

•Updated and maintained document databases

•Performed data entry for tracking documents and weekly metrics

•Coordinated projects with QAO and other departments to meet deadlines

•Prepared boxes to be shipped to offsite storage

•Prepared documents to be sent off-site and stored

Vericel Corporation, Cambridge, MA (6-month contract) November 2017 – May 2018

Quality Assurance Compliance

•Responsible for label making for manufacturing and final packaging

•Archiving and Retrieval of files from Iron Mountain

•Implemented new batch records, Logbooks, and SOPs

•Prepared biopsy accessioning kits

•Prepared batch records for media and cell culture processing

•Reviewed and closed out batch records

•Updated documents and spreadsheets in EDMS

•Reviewed inspection records for all biopsies received

•Allocated and verified controlled batch records and lot numbers associated with manufacturing

•Assigned batch records and lot numbers

•Ensured all documents submitted are accurate and final review has been done

Finch Therapeutics, Somerville, MA (3-month contract) August 2017- October 2017

Quality Assurance Assistant

•Sort and file batch records

•Assist with backlog of batch records

•Verify and review batch records for final release

•Track and log all batch records

•Reduce a high volume of backlog down to current date within 6 weeks

•Prepare files for destruction and archiving

Umass Medical School-Mass biologics, Boston, MA May 2017- July2017

Quality Assurance/ Quality Control Intern

•Filing and archiving within cGMP guidelines

•Implementing of new IPs, Logbooks, SOPs

•Ensure all documents submitted are accurate and final review has been done

•Maintain all master files

•Update and process documents through Master Control

•Access databases that are utilized for tracking and management of the high volume of documentation flowing between related departments

•Creates and organizes systems for filing and tracking GMP related records and documentation

•Reviews documents to ensure that cGMP documentation meets in-house and cGMP requirements

Vericel Corporation (3-month contract) October 2016-November 2016

Quality Assurance-TrackWise Data Specialist

•Participated as a key member of the QA TrackWise implementation and data entry of Deviations, Investigations, CAPA, and Change Control

•Successfully expedited completion of the TrackWise project from 3 months to 1 month

•Archived GMP Documents (ie Batch Records and R&D records) as part of the record retention and document control program

•Ensured TrackWise project decisions were made on sound Quality principles and regulatory guidelines related to electronic systems

•Allocated and verified controlled batch records and associated SOPs to manufacturing

•Supported the Site Project Manager with SOP verification related to new product launch

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