Jacqueline Moore Email & Phone Number

Phoenix, AZ, US

Amsterdam, 1105BP, NL

• Oversight and training of QADC staff
• Ensure appropriate version of Effective document(s) or retired document(s) are readily accessible in electronic and/or hard copy form (may involve maintaining gown qualification for cleanroom access)
• Assists in System Administration of Electronic Document Management and Learning Management System (EDMS/LMS) including performance of troubleshooting, annual upgrade assessments, audit trail review, configuration to.
• Perform and oversee on-site document archival, and offsite document archival with approved vendors
• Issuance, tracking, reconciliation and archival of Controlled Documents including electronic and hard copy
• Ensures documents meet formatting and template requirements, adhere to required review and approval requirements and project timelines

Lawrence Township, NJ, US

• Authored the Annual Product Quality Review (AQPR) Reports for Drug Substance (DS) and Drug Product (DP) for EmplicitiTM (elotuzumab)
• Managed the document change control process, coordinated cross functional reviews, approvals and effective targets in alignment with requirements (cGMP and BMS) and customer needs
• Served as a subject matter expert (SME) for the electronic document management system
• Lead investigations for Low Risk Deviations.
• Developed controls for the issuance and reconciliation of Controlled Posted Signage for the site
• Facilitated Quality Unit Focus Groups for “Speak My Mind”

Lawrence Township, NJ, US

• Managed the document change control process, coordinated cross functional reviews, approvals and effective targets in alignment with requirements (cGMP and BMS) and customer needs
• Executed the initiation, processing, routing, distribution and archiving of cGMP documentation and facilitated the compliance of site documentation
• Served as a subject matter expert (SME) for the electronic document management system
• Provided backroom support during in regulatory agency inspections and corporate audits including the provision of system reports using Audit Utopia
• Managed the electronic issuance and lifecycle of batch records and logbooks
• Regularly suggested new ideas for problem solving

Amsterdam, 1105BP, NL

• Responsible for planning and implementing activities related to document and record control.
• Maintain and develop the Controlled Document Master List and other tracking database tools as needed.
• Ensure that all procedures are reviewed and updated at least annually per internal requirements.
• Prepare routine updates and project status reports of QA Document Control and Quality Assurance activities.
• Continually provide guidance to all employees related to document control policies and procedures.
• Perform other quality systems assignments and projects as assigned to ensure compliance with QMS.

Amsterdam, 1105BP, NL

• Maintained the Document Control System and Processed Documents including formatting, numbering, record retention and change control.
• Managed all Documentation Control Activities.
• Created Document Control Procedures such as Document Control Process, Logbook Issuance and Usage Procedure, Maintaining and Archiving of GMP Documentation, Biennial Review of SOPs and Associated Documentation.
• Assisted in the creation of Quality System Procedures such as Internal Audit Procedure, Vendor Audit Procedure, Deviation and Investigation Procedures.
• Created the Training Program and maintained the Training Database.
• Conducted training presentations on Quality System Procedures such as the Training Program and Good Documentation Practice Procedures.

• Assisting QSDC Specialist I in activities related to the generation, revision, tracking, approval and archiving of required GxP documentations (SOPs, Specifications, Work Instructions and Forms) using Microsoft Office.
• Maintaining daily, weekly and monthly organization of training files, QA Memo Log Books, Deviation Log Books, Local SOP Books, Internal Audit Books and Change Control Books.
• Preparation/review of Computer Validation Systems for relocation as well as implementing an organized method through creating Excel spreadsheets and generating structured filing/tracking records.
• Administrative reconciliation of training files, QA Memo Log Books, Deviation Log Books, Local SOP Books, Internal Audit Books, and Change Control Books.
• Basic clerical work of copying, scanning, and printing documents as well as creating labels for any Form’s/SOP’s.
• Creating/implementing ideas to better organize the department and its documents.

• Administrative reconciliation of safety electronic and hardcopy data files
• Preparation of file documents for data migration, including but not limited to creating Excel Spreadsheets, generating system reports and file records, tracking records, use of Clintrace database for data entry
• Manage sensitive/confidential data and protecting the security of the data
• Various projects to support safety system validation and data migrationCreating methods to better organize Clinical Drug Safety and its documents/systems such as new Excel Spreadsheet, Clintrace coversheets in case.

Bachelor’S Degree, Biology, General

Associate’S Degree, Liberal Arts And Sciences/Liberal Studies

Biology, General