EDWARD JACKSON II
North Chicago,IL
Summary
Experienced pharmaceutical professional with advanced skills in document control, project leadership, records management, training, and quality control. Proven track record in effectively managing records while adhering to the stringent guidelines of a research and development organization. Extensive experience in overseeing and implementing quality control measures to ensure compliance and efficiency. Adept at leading projects and teams to successful outcomes through strategic planning and meticulous attention to detail.
Overview
29
29
years of professional experience
Work History
Senior Specialist QA Document Control
Bristol Myers Squibb
07.2023 - Current
- Served as subject matter expert on Electronic Document Management System (EDMS)
- Executes the initiation, processing, routing, distribution and archiving of GMP documentation
- Provides direct Records Management support during regulatory agency inspections and corporate audits.
- Supported department leadership in implementing new global and site policies, procedures and controls.
- Create and reconcile batch records and log books as needed.
Quality Assurance Document Control Associate
Novartis Gene Therapies
01.2022 - 01.2023
- Issue controlled documents: Master Batch Records, Logbooks, and various documents
- Manage electronic workflows for review/approval of workload to meet the needs of business partners.
- Daily production line inspection monitoring for GMP and GDP issues before the run ends.
- Generate Specifications for incoming raw materials.
- Provide training to new staff on document processes and procedures.
- Review logbooks from Quality Control, Manufacturing, Warehouse, and Income Quality
- Issue Finished goods Batch records and labels.
- Manage storage for controlled and technical documents for the company.
- Assist in training on documentation and record retention procedures and instructions to other departments.
- Process documents through CONDOR, ARONDA, and ACE systems.
- Log, track and maintain status of all Batch Records and supporting documents.
- Upload transmittal documents into SharePoint as well as capture the correct metadata before routing the transmittals internally.
- Provide customer service to business partners locally and globally.
Q A Document Specialists III (Contract)
AbbVie Pharmaceuticals
06.2021 - 01.2022
- Upload various documents into Attache Pro
- QC and quality check documents in Attache Pro for accuracy before approval
- Enter executed batch records into HPE (RIM) for archival
- Box up files and complete a box contents report for boxes going to offsite storage
- Use Attache to look up batch records to create labels with the EMR numbers
- Make sure records and file room is audit ready
Quality Document Coordinator
Sunset Healthcare Solutions
01.2021 - 05.2021
- Author and implement Standard Operating Procedures (SOP’s) and Work Instructions
- Manage new inspections and enters inspection results into the QT9 system
- Manage and file customer feedback and supplier information
- Monitor and track completion of employee trainings in the Learning Management System (LMS)
- Archive complaint records and other pertinent information
- Direct contact for vendors on new parts
Document Specialist (Contractor)
AbbVie Pharmaceuticals
02.2020 - 11.2020
- Maintain efficient record-keeping systems that enable fast and easy access to critical information
- Scan and data enter records consistent with documentation practices across the company
- Utilize storage software and applications to file documents electronically
- Retrieve and control document access upon request
Records Management System Manager
Takeda Pharmaceuticals
10.2013 - 08.2019
- Business System Owner of HPE Records Management System (HPE)
- Ensured the consistent and compliant operation of the Records Management System
- Verified document integrity and ensured records were archived according to regulatory requirements
- Managed multiple document types: ex. CMC, GMP, GLP, Legal contracts, Validation, Marketing and etc.
- Implemented corrective actions when non-compliant or erroneous data was noted
- Authorized training materials and user manuals related to system configuration, controls, and its proper use
- Managed data change modifications related to data quality assurance or other business-related changes
- Provided on-demand support and training for internal customers on documentation and storage system
- Represented Records Operations at stakeholder meetings for ongoing and prospective storage projects
- Administered and maintained user accounts for records storage system
- Direct contact for retrieving documents for internal audits and investigations
- Managed 3rd party vendor activities supporting record processes
Records Coordinator
Takeda Pharmaceuticals
07.2008 - 10.2013
- Developed training and communications for records software enhancements
- Performed quality checks on all records entered in an electronic records repository to ensure accuracy
- Lead records integration project to merge large record sets from companies acquired by Takeda
- Processed complex requests for records that require advanced searching skills
- Provided accurate, efficient, courteous records management services to internal customers
- Developed and reviewed policies, procedures and guidelines to ensure full compliance
- Trained Records Operation Center personnel on records management and software
- Analyzed and communicated project risks and issues as necessary
Records Operation Team Leader
TAP Pharmaceuticals
07.2006 - 07.2008
- Provided daily leadership to Records Operations personnel
- Liaison between the department and customers to ensure efficient support for records management
- Managed and prioritized 3rd party vendor activities to support records management
- Managed daily communication to support record efficiency, storage effectiveness and compliance
- Authored Standard Operating Procedures and department work directives
Records Management Technician II
TAP Pharmaceuticals
04.2002 - 07.2006
- Identified and indexed Clinical and Regulatory submission records and prepared for data entry into electronic records management software
- Assisted internal customers on records procedures, receipt of documents and retrieval of information
- Performed periodic transfers of inactive and archived records to offsite storage facilities
- Trained new employees in records management and electronic records management software
- Provided leadership to employees on data entry procedures and electronic filing software
Mail Specialist
06.1996 - 04.2002
- Lead large scaled shipment projects for National Meetings to ensure bulk packages arrived without damage and within specified timeframes
- Managed vendors to ensure excellent quality, customer service, and cost-effective shipments
- Sorted and distributed daily incoming and outgoing mail and packages
- Prepared parcels for mailings with FedEx, UPS, and US Postal Service
- Supervised day-to-day operations of company mail center
- Provided training to new employees on policies, procedures and guidelines of the mail center
Education
High School Diploma - General Studies
North Chicago Community High School
06.1997
Skills
- Leadership Experience
- Management Experience
- Teamwork
- Project Management
- Records Management
- Customer Service
- Vendor Management
- Process Improvement
- Communication/Training
Timeline
Senior Specialist QA Document Control
Bristol Myers Squibb
07.2023 - Current
Quality Assurance Document Control Associate
Novartis Gene Therapies
01.2022 - 01.2023
Q A Document Specialists III (Contract)
AbbVie Pharmaceuticals
06.2021 - 01.2022
Quality Document Coordinator
Sunset Healthcare Solutions
01.2021 - 05.2021
Document Specialist (Contractor)
AbbVie Pharmaceuticals
02.2020 - 11.2020
Records Management System Manager
Takeda Pharmaceuticals
10.2013 - 08.2019
Records Coordinator
Takeda Pharmaceuticals
07.2008 - 10.2013
Records Operation Team Leader
TAP Pharmaceuticals
07.2006 - 07.2008
Records Management Technician II
TAP Pharmaceuticals
04.2002 - 07.2006
Mail Specialist
06.1996 - 04.2002
High School Diploma - General Studies
North Chicago Community High School
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