Jacqueline Moore Email & Phone Number

Phoenix, Az, Us

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 support operational needs• 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• Perform trouble shooting of EDMS/LMS issues, including password reset and system functionality.• Issues unique identifiers, maintains tracking tools, trends and audits Quality Management System (QMS) documentation• Own Change Controls/Corrective Actions- Preventative Actions/Deviations relative to QADC and EDMS/LMS• Perform other related duties and responsibilities as needed.

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”• Coached and mentored my colleagues with good intent and purpose by continually being available for questions, educating and maintaining exceptional customer service• Implemented multiple new processes to consolidate the Records Management Archiving room such the creation of the HPE CM Work Instruction, organized the records archived to assist customers locating records, utilized HPE CM to generate new locations for in-process archiving, auditing and off-site staging. • Supported Global Quality Audits by fulfilling backroom requests and attending closeout meetings as the Records Management representative. • Completed Lead Investigator Training for Medium and High Risk Investigations.• Sought and shared bold ideas that include the addition of adding the criticality rating of forms on the template for Form creation. • Managed the electronic issuance and lifecycle of batch records and logbooks• Continuing to perform job duties as seen in Records Management Specialist description.

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• Assisted in the maintenance and upkeep of Quality System Procedures such as Records Management Procedure, Training Procedure and Good Documentation Practices.• Created and implemented checklists using yellow belt techniques for the use of the EDMS system • Managed multiple tasks in a fast paced and dynamic environment while maintaining focus on quality and compliance with local SOPs, policies and directives, and regulatory requirements.• Ensured controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures• Developed and designed templates to standardize documents within the EDMS system

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.• Support in maintaining the following databases:o Training Program, Assay ID Issuance/Tracking, Logbook Issuance/Tracking, Batch Number Issuance (Manufacturing and Process Development), Document Change Request Issuance/Tracking, etc. o Master Document Tracker (New, Revised and Retired Documents), Part Number Issuance, SOP Reference Tracker, and Document Numbering Matrix.• Create and assist in the creation of Quality System Procedures such as Document Control Program, Training Program, Good Documentation Practices, Deviation and Investigation Procedures, Corrective and Preventive Corrective Action Program (CAPA), Change Control Program and Signature Verification. • Support department system activities, including trend analysis, batch review/lot release and internal audit activities.• Responsible for clerical and administrative duties related to training and organizational development. Schedules training events, hires instructors, obtains instructional materials, and ensures employees are kept abreast of training requirements.• Responsible for maintaining and coordinating internal QMS Training program.• Ensure completeness and file all company quality training plans and records quickly and accurately.• Maintain training metrics and training spreadsheet, and produce training compliance reports.

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, Controlled Document Numbering and Document Control Storage Rooms Procedure.• 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. • Processed employee training requests and updated master training plan accordingly.• Conducted training presentations on Document Control Systems.• Performed Internal Audits on documentation such as Validation Documentation. • Issuance and control of part numbers and logbooks for Quality Control, Supply Chain, Quality Assurance and Manufacturing.• Administered electronic tracking systems for Quality Systems and issued monthly reports. • Filed and archived engineering change management forms, engineering numbering requests, engineering drawings, etc.• Created Quality Systems Procedures such as Good Documentation Practice, Training Program and Signature Verification.• Maintained the Auditing Tracking Database for External and Internal Audits.• Supported in the creation, review and approval of SOPs, Batch Records, Material Specs. and Test Records. • Tracked documents during the Routing, Review and Approval Process.• Maintained, filed and archived Master Documents such as SOPs, Forms, Certificates of Analyses, Validation Documentation, Training Records, etc.• Supervised Document Control Temp. in daily Document Control Activities.

• 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 and hardcopy system. • 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.• Providing Internal Audits around the QA (Quality Assurance) Department including but not limited to GLP (Good Laboratory Practice), QSDC (Quality Systems Document Control), etc.

• 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 study folders, labeling, etc.

Bachelor’S Degree, Biology, General

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

Biology, General