Records Specialist Executive Assistant

Lisa Ann Carlson

*** **** ***** ***** 862-***-****

Sparta, NJ 07871 *****************@*****.***

http://www.linkedin.com/pub/lisa-carlson/27/727/555 Qualified trainer and systems specialist with 25 years of diverse experience in the pharmaceutical industry, specializing in following:

LMS – ComplianceWire / SumTotal Validation / UAT / Script Writing SOP Preparation Training Curriculum Development cGMP / AE / GCP Compliance Deviations System Training Audit/Inspection Readiness Project Management PROFESSIONAL EXPERIENCE

Akorn Pharmaceuticals, Somerset and Cranbury, NJ

Manager, Quality Assurance Training, Quality Assurance 4/2022-10/2022 (Site Closures) Project Lead – Akorn Decommissioning Project

Managed the training programs at both the Somerset and Cranbury, NJ sites for Production and R&D.

Managed (2) Training Specialists.

Managed the Learning Management System (ComplianceWire).

Processed Instructor-Led training, on-the-job training and self-trained training into the learning management system.

Handled training for Aseptic Core Monitoring, Chemistry, Microbiology, R&D, Quality Assurance and Production.

Managed and updated training curriculums as required.

Reviewed and approved Document Change Requests for SOPs to determine training requirements.

Uploaded new/revised SOPs & quizzes into the LMS. Worked with documentation in Veeva Vault QD.

Trained new hires on GMP, GDP, Data Integrity and Safety EH&S.

Reviewed and approved internal audit reports.

Served as a member and prepared monthly and quarterly training compliance reports for the Corporate Leadership Team.

Worked to resolve inspection findings.

Led the Akorn Decommissioning Team to successfully decommission all GxP documentation across (3) sites.

Hired and supervised team of (18) personnel.

Managed project teams, daily assignments and provided weekly progress updates to management and corporate.

Available for immediate employment.

SHIONOGI INC., Florham Park, NJ

Manager, Quality Assurance Training, Quality Assurance 2020 – 2022 Manager, Quality Assurance Training, Quality Assurance (Supervisory) 2018 – 2020 Senior Quality Assurance Trainer, Quality Assurance 2016 – 2018 Quality Trainer, Quality Assurance 2012 – 2016

Responsible for managing all corporate training in the NJ and ATL offices for GxP areas such as: Quality Assurance, Pharmaceutical Sciences, Regulatory Affairs (GDP and CMC), Clinical Development, Drug Safety, Biometrics, Data Management, Medical Affairs, Medical Information, Information Technology, Supply Chain and Warehouse, as well as non-GXP areas such as: Human Resources, Marketing, Market Access, Finance & Accounting, Legal, Compliance, In-house Sales, Commercial Strategy and Business Development.

Supervised one direct report: Quality Assurance Training Associate.

Highest Level Organization Administrator (1 of 2 for the entire company) and System Owner representing Quality Assurance for ComplianceWire, the corporate learning management system (LMS).

Responsible for reviewing and approving all validation documents such as System Validation Plan, User Requirements Specifications, Operational and Performance Qualification Test Scripts, Modified Performance Qualification, Protocols, Traceability Matrix, Validation Summary Report and HRMS Test Scripts.

Developed and authored Standard Operating Procedures, Forms and Policies for local training.

Developed and prepared training material (i.e., power point presentations, assessments, and handouts) for local and Global SOPs/policies/forms and other specific cGMP, GCP and industry regulated topics.

Ensured internal tracking logs/system for training were maintained, accurate and reportable.

Ensured electronic, paper files and training database were maintained.

Developed a new hire Employee Training Plan of training requirements for all new personnel and updated as appropriate. Tracked training from initiation through completion for compliance.

Created departmental training matrices for all GxP and non-GxP areas based off a matrix schedule on an annual basis. Negotiated appropriate training and training levels with department heads.

Performed gap analysis of personnel training files against current departmental training matrix to ensure compliance with training requirements and updated personnel training plans as appropriate.

Responsible for heading up the QA/RA Monthly Training Initiative providing continuous education through securing internal and external presenters, offering robust webinars and e-lessons, geared toward fundamentals, improving skill sets, leadership, and creativity.

Presented at HR on-boarding sessions to new hires on their training requirements, reviewed good documentation practices (GDocP) and their role and responsibilities. Increase seen in compliance.

Consistently looked at process improvements for the QA Training Department.

Selected as a member of the LMS Core Team, serving as the Training and QA Representative for an initiative to bring a corporate electronic learning management system in-house.

Created and delivered mandatory corporate cGMP training to personnel on an annual basis via a recorded WebEx and tracked for 100% compliance. Created and provided recorded WebEx cGMP training to the Sales Field Force. Provided oversight on deployment and tracked mandatory Adverse Event Reporting training conducted by Drug Safety for 100% compliance.

Worked closely with management to ensure that cGMP (Current Good Manufacturing Practices) and FDA compliance requirements were followed.

Interacted with all levels of personnel, senior management and at the Operating Committee level daily with determining training requirements, preparing, and delivering training, reviewing good documentation practices, reconciling training, reporting and escalation.

Built strong interpersonal relationships with business stakeholders across all departments within the company.

Performed Root Cause Analysis on deviations to internal training processes and deviations to SOPs.

Responded proactively and with urgency to CAPAs. Performed immediate corrective action and provided written response to Senior Management for closure.

Prepared and responded to various internal and regulatory audits as SME. Designated with the responsibility of providing all training documentation and tracking and logging all corporate documentation provided to the FDA or regulatory agency.

Co-created and maintained the QA home page on the Shionogi Connection (internal website.)

Performed execution of test scripts for the validation of TrackWise 8.3.1 system.

Assisted with the quality review of GMP documentation placed into product binders for the Shionogi Inc. portfolio.

QA Documentation Control Coordinator, Quality Assurance 2011 - 2012 Responsible for the review and maintenance of all (26) product binders in the Shionogi Inc. portfolio. Consulted with Product Assessors and CMOs to ensure current document versions were in place. Ensured documents in product binders accurately reflected table of contents and server. Ensured updates were incorporated in a timely manner to maintain compliance. Established standards in documentation to be included in binders. Maintained current and obsolete files on server, created naming convention for files and organized all folders on server. Liaised with Regulatory Labeling to ensure current approved labeling was provided. Notified and provided Atlanta office with documentation updates to be used in manufacturing. Created metrics for binder updates and provided to upper management monthly.

Handled Product Specifications, Quality Agreements, Manufacturing Batch Records, Packaging Batch Records, Raw Materials, Component Specifications, Validation Protocols and Reports, Stability Protocols, Test Methods, Package Inserts and Labeling (Bottle Labels, Cartons, Trays, and Physician Samples).

Assisted with the review and closure of manual change controls for former Shionogi Inc. Atlanta and Ireland files. Updated product binders as necessary.

Responsible for ensuring SOPs and associated documentation were made obsolete and effective in a timely manner. Ensured server, SOP binders, table of contents and files were updated.

Served as departmental back-up for providing New Hires with appropriate training matrix and welcome information.

Initiated document change requests for new/revised/obsoleted SOPs and Forms.

Web content co-manager of the Quality Assurance homepage.

Created departmental guidelines on SOP Obsoletion/Effective Process and New Hire Process.

Assured that cGMP (Current Good Manufacturing Practices) and FDA compliance requirements were followed.

Performed execution of test scripts for the validation of TrackWise 8.3.1 system.

Assisted in the preparation and tracking of documentation requested during FDA inspections. Created inventory log of all requested documentation and created binders.

Assisted in other quality assurance and compliance functions as needed. HOFFMANN-LA ROCHE INC., Nutley, NJ

Executive Assistant, Product Development Quality Process Management & Training 2009 - 2011 Learning Management System (LMS) administrator and co-trainer for the US. Global mentor to colleagues on the functionality of LMS. Provided hands-on instructional classroom training to new administrators. Created and prepared training materials and reviewed/graded training exercises. Responsible for creating parent courses, child sessions, global audiences and assigning all training to new hires. Ensured 120 new hire employees (USA, UK, Switzerland, and China) received the appropriate LMS eLearning, web-based training (WBT) modules to perform their jobs and maintained compliance. Worked with department heads to ensure multi-departmental key training grids (Matrices) for new hire assignments reflected accurate training roles and needs and were kept current. Analyzed gaps in training on new controlled documents and recommended a gap resolution. Resolved validation issues in LMS and granted system access. Served as a member of Global LMS Core Team for technical issues and process improvements. Provided monthly gap analysis reports to management on employee training non-compliance.

System Architect system administrator, responsible for mapping business processes and promoting new methodology.

Documentum System Administrator, responsible for the creation, review, and management of the approval/withdrawal of controlled documents such as Standard Operating Procedures (SOPs), Supporting Documents (SPTs), Forms and Guidelines.

Independent Project Team Lead on the Pharmaceutical Quality System Project, responsible for the mapping of cross-functional business processes and the creation and review of content for SOPs, SPTs, Forms and Guidelines.

Co-led the development and management of global cross-functional documents and guidelines.

Web content manager of the GCP Resource Center and Intranet.

Quality contact for User Acceptance Testing for organizational databases.

Member of the Roche Records Management Steering Committee. Executive Assistant, Pharma Development Central Services 2007 – 2009 SME on the management of case report forms and technical expertise within the Data Handling and PD38 Form working groups. Learning Management System (LMS) administrator responsible for creating parent courses and child sessions and assigning training to users. Mentored colleagues on the functionality of LMS. Formatted Standard Operating Procedures (SOPs), assigning attributes, and performing searches within Documentum. Mentored colleagues on the functionality of Documentum. Updated and posted documents to the Intranet and assigned permissions to users.

Department Lead responsible for the delegation and supervision of projects to a team of 3.

Created Visio maps for departmental processes to enhance SOPs and presentations.

Standardized documentation formats by creating naming convention processes for Pharma Development Annotated Forms and wrote guidelines.

Supported team of seven managers and departmental site head with expenses, travel, meeting/LiveMeeting/VC/TC arrangements, face to face planning, venue contracts, attendance and ensured budget maintained.

Sr. Administrative Assistant, Standards & Compliance 2007 Assembled, printed, and distributed CTMS training material globally to trainers. Initiated grants and processed invoices for all consultants and new hires. Managed the relocation of 30 employees into new office space. Liaised with Management, Facility Planning, Building Managers, Move Line, IT and Voice Communications. Adhoc member of Nutley Leadership Administration Team and Lead Administration Team. Supported team of 8 managers with attendance, travel, expenses, meeting planning and budget oversight.

Case Report Form Design Analyst, CRF Design & Data Integrity 2003 – 2007 Designed and produced paper and electronic Case Report Forms (CRFs) based on clinical trial protocols. Collaborated with Study Management Teams (USA, UK, and Switzerland) during design and incorporated global comments. Trained in electronic data capture for eCRFs. Created Data Collection Specifications

(DCS) and Macro Study Data Specifications (MSDS) for programming instruction. Reviewed CRF proofs prior to printing and coordinated production and shipping to investigational sites. Archived CRFs as per corporate guidelines.

Ensured the use of CRF design standards to provide maximum efficiency.

Designed and maintained CRF and eCRF modules to comply with data-model/database standards.

Designed therapeutic studies for rheumatoid arthritis and solid growth tumors.

Designed Quality of Life questionnaires.

Designed marketing studies for heart transplantation, post-operative nausea and vomiting in pediatrics and several osteoporosis/osteopenia studies for Boniva®.

Designed clinical pharmacology studies for Type 2 Diabetes, Erectile Dysfunction, Alzheimer’s disease, and various dosing studies.

Lead Documentation Records Specialist, Quality Management/Technical Operations 2000 - 2003 Delegated and supervised projects to a team of 5. Member of the QM Inspection Team for FDA audits and various regulated inspections (Russia, Canada, Saudi Arabia, and EU). Tracked and maintained in a secure environment - Standard Operating Procedures (SOPs), Supporting Documents (SPTs), Investigation Reports

(IRs), Addendums, Follow-Ups, Specifications and Directions for Testing, Certificates of Analysis, Active Pharmaceutical Ingredients, Laboratory Notebooks and Annual Reports. Filled internal/global requests for all documentation types and archived documentation per corporate guidelines.

Developed a database and filing system to enhance the tracking of Certificates of Analysis.

Documentum SuperUser, responsible for the initiation and completion of controlled SOPs/SPTs and to ensure distribution/filing and compliance. Delegated SOP workload and tracked status

Tracked, formatted, queried, entered, and maintained all Investigation Reports, Addendums, Follow- Ups, and Product Complaints via TrackWise Tracking System database.

Streamlined SOP process by formatting to corporate guidelines.

Interacted with Manufacturing Team Leaders to incorporate changes into IRs and Follow-Ups.

Ensured through follow-up that IRs were closed by due date and provided status reports to VP of Manufacturing.

Audited monthly SOP binder for all of manufacturing.

Formatted molecular structures to be included within Specifications and Directions for Testing documents.

Formatted Master Batch Records due for revision and issued additional pages to production personnel. Administrative Assistant, US Clinical Operations Contracts Office 1996 – 2000 Typed, prepared, and distributed all clinical contracts, addendums and riders for Physicians, Institutions, CROs and Consultants. Collaborated with the Law Department on contracts. Maintained Contract Office Access database to track movement and status of contracts from initiation to completion.

Created and maintained disaster recovery files and implemented an electronic filing system to create a paperless environment via scanning.

Trained Clinical Research Associates and Study Management Teams on the contracts system.

Coordinated the first Clinical Research Organization Fair for US Clinical Operations.

Supported a team of 5 with attendance, travel, expense reports, VC/TC, and meeting arrangements. EXPERTISE

Software: Excel, Word, PowerPoint, Outlook, Visio, Articulate Storyline, Articulate Rise 360 Systems: Learning Management Systems (ComplianceWire, SumTotal), Veeva Vault QD, SharePoint

(EDMS) (Web Administration), QUMAS, Documentum, TrackWise System, Quicksilver w/ CDT, EDiCT and Concur

Misc.: WebEx, Recorded WebEx, Skype, Teams, DocuSign, scanning and type 65+ wpm. Certifications: Articulate Storyline

EDUCATION

BFA - Visual Communications, Caldwell University, Caldwell, NJ

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