Quality Control Assurance

Kenneth Bean

SUMMARY

Highly skilled quality/ validation consultant with diversified domestic and international experience and a background that incorporates strong technical orientation with business skills.

Hold a proven record of success in product development, process improvement, cGMP compliance, validation, and quality control.

Classical Training in both science and technology.

Thermo Fisher Software packages: Sample Manager, Watson, Darwin, V.G.L. coding

Water Empower and NuGenesis certified.

Veeva Q.M.S.

Oracle Db10g suite/ configuration and support

Knowledgeable regarding drug development from experimental phases to clinical trials/manufacturing.

Extensive validation experience involving hardware, equipment (including robotics), software, and I.T. infrastructures. I have completed over 85 projects for mission-critical applications involving clinical trials, E.D.C., ERP, LIMS, LEMS, SLIMS, lab systems, and manufacturing.

Involved with F.D.A. audits, submission approaches, and processes for numerous pharmaceutical and medical device clients. Compliance experience with F.D.A., N.I.H., ICH, ISO, IEEE, GAMP, and D.E.A.

Fully conversant in 21 C.F.R. Part 11 and best business practices impacting regulatory, clinical, manufacturing, and safety groups.

SAP-QM-xMII support for M.E.S./ product release.

PROFESSIONAL EXPERIENCE:

Cell Therapy Jun 2022-Jan 2025

Senior QA Consultant LIMS, AI/ML, and IT systems.

Oversaw the quality assurance of Laboratory Information Management Systems (LIMS), ensuring robustness and compliance.

SME/Team lead in integrating and validating AI and Machine Learning (ML) technologies within LIMS and IT frameworks.

Develop and implement QA strategies and methodologies for AI/ML applications.

Lead the design and execution of system testing, including functional, regression, and performance tests.

Directed the integration, configuration, and complete validation of NuGenesis and Empower systems at four distinct global sites.

Oversaw workflows from administrative setup through detailed implementation, ensuring robust compliance and operational excellence.

Conducted comprehensive system validations to meet regulatory standards, including IQ, OQ, PQ, and UAT.

Provided end-to-end support for Empower integration, enhancing chromatography data management and reporting capabilities.

Conducted comprehensive system validations to meet regulatory standards, including IQ, OQ, PQ, and UAT.

Provided end-to-end support for Empower integration, enhancing chromatography data management and reporting capabilities.

Manage risk assessment and mitigation plans for AI/ML projects.

Collaborate with IT and development teams to enhance system reliability and efficiency.

Provide technical guidance and mentorship to QA teams.

Oversee project timelines, ensuring timely delivery of milestones.

Stay abreast of emerging trends in AI/ML and LIMS technologies.

Facilitate continuous improvement through process optimization and innovative solutions.

Act as a key liaison between technical teams and stakeholders.

Takeda Pharmaceuticals remote. 1.6 years Jan- Jun2022

QA Manager

LIMS (Laboratory Information Management Systems) Management:

oSuccessfully maintained and updated the LIMS to ensure compliance with regulatory standards and internal company policies.

oCollaborated with laboratory staff to understand their needs, resulting in optimized LIMS workflows that enhanced sample tracking, data management, and reporting capabilities.

oConducted regular LIMS system validations to ensure accuracy and efficiency.

Quality Assurance in Bioanalytical Systems:

oLed the bioanalytical methods and equipment validation, ensuring their accuracy and regulatory compliance.

oVigilantly monitored data integrity in bioanalytical processes, strictly adhering to Good Laboratory Practices (GLP).

oProvided essential QA support during bioanalytical studies, contributing to successful audits and inspections.

SAP System Management:

oPlayed a key role in aligning SAP system processes with pharmaceutical quality standards, enhancing operational efficiency.

oExpertly managed SAP configurations and customizations, particularly for supply chain and financial operations, ensuring smooth and compliant processes.

oFacilitated effective collaboration between IT and various business units, leading to significant improvements in SAP system performance and compliance.

SaaS Systems Oversight:

oOversaw the integration, performance, and compliance of various SaaS platforms utilized across the company.

oEnsured that all SaaS applications consistently met data privacy and security regulations.

oEffectively coordinated with vendors for timely system updates, issue resolutions, and compliance audits.

Spearheaded NuGenesis and Empower upgrades, achieving seamless data migration and system enhancements across multiple sites.

Executed site-specific configurations to streamline laboratory workflows, improving data traceability and operational efficiency.

Collaborated with cross-functional teams to validate and implement systems that adhered to FDA and global regulatory standards.

Cross-Functional Collaboration and Leadership:

oActively collaborated with multiple departments including IT, laboratories, regulatory affairs, and business units, fostering an environment of teamwork and shared goals.

oLed several cross-departmental projects aimed at implementing new technologies and improving processes, demonstrating strong leadership and project management skills.

Documentation, Reporting, and Communication:

oMaintained meticulous records of system validations, audits, and corrective actions, contributing to the company's high standards of record-keeping.

oDeveloped and delivered comprehensive reports on system performance, quality issues, and continuous improvement initiatives, enhancing organizational transparency and decision-making.

Continuous Improvement and Professional Development:

oKept abreast of industry trends and regulatory updates relevant to LIMS, bioanalytical, SAP, and SaaS systems, applying this knowledge to continuous improvement efforts.

oRegularly identified and implemented process improvements, showcasing a commitment to excellence and innovation in quality assurance practices.

Pharmacovigilance Systems Management:

oEnsured the pharmacovigilance software systems were consistently compliant with global regulatory requirements, including FDA, EMA, and ICH guidelines.

oConducted thorough validations and verifications of pharmacovigilance systems to ensure accurate and efficient adverse event reporting and drug safety monitoring.

Quality Assurance and Compliance:

oMaintained a rigorous QA process for all pharmacovigilance activities, ensuring data integrity and compliance with standard operating procedures (SOPs) and regulatory standards.

oLed internal and external audits of pharmacovigilance systems, addressing any findings and implementing corrective actions to prevent recurrence.

Cross-Functional Collaboration:

oWorked closely with pharmacovigilance teams, IT, regulatory affairs, and other relevant departments to ensure seamless integration and functionality of the software systems.

oParticipated in cross-functional team meetings to provide QA insights and updates, ensuring alignment of pharmacovigilance activities with overall company objectives.

Risk Management and Mitigation:

oIdentified potential risks in pharmacovigilance processes and software systems, implementing risk management strategies to mitigate these risks.

oStayed updated with changes in pharmacovigilance regulations and guidelines, adapting QA processes to ensure continued compliance.

Process Improvement and Innovation:

oContinually assessed and improved pharmacovigilance systems and QA processes to enhance efficiency, accuracy, and compliance.

oImplemented innovative solutions and technologies to streamline pharmacovigilance activities and data management.

Reporting and Documentation:

oPrepared detailed reports and documentation on system validations, audit findings, and QA activities, contributing to transparent and effective communication across the company.

oEnsured all pharmacovigilance-related documentation was accurate, up-to-date, and readily available for audits and inspections.

Jabil Medical Device was remote. 1.5 years May-2021 Dec-2021

Team Lead for Global Quality

Computer Systems Validation (CSV) S.O.P.

I.T. Training material for CSV

Vendor Audits

Ensuring Global Processes are in place related to ERES:

oUS, Canada, Germany, Japan, Mexico, Israel, Argentina, Mexico, Haiti

I.T. Change Management

Incident and Problem Management S.O.P.

QMS/ IT controls upgrading to Veeva

Worked with other T.C.S. sites to bring in T.C.S. Resources

A.S.P.

Lead Quality/I.T. Validation. Remote two years 2019 -2021

Worked with other T.C.S. sites to bring in T.C.S. Resources

SAP, ServiceNow, Q.M.S.,

oSystems Development Lifecycle (SDLC)

oComputer Systems Validation (CSV) S.O.P.

oComputer Systems Master Validation Plan

oI.T. Change Management S.O.P.

oIncident and Problem Management S.O.P.

oRelease Management S.O.P.

o21CFR Part 11 S.O.P.

oGood Electronic Practices S.O.P.

Creation of project documentation: Proposals, Charters, Plans, User Requirement Specifications (U.R.S.), Functional, Design, and Architecture Specifications, Traceability Matrixes, Work Breakdown Structures (WBS), Support Plans, Release Plans, and Release Memos.

Controlled validation document creation, execution, and review: Validation Assessments, Validation Plans,

Installation Qualification (I.Q.), Operational Qualification (OQ), Performance Qualification (P.Q.), and User Acceptance Testing (UAT).

Formulate planning, budgeting, forecasting, and reporting strategies.

Manage full life cycle implementations.

Contracted to Dow Chemical remote one the year 2018-2019

1.Project Portfolio

a.Trinseo Uplift

i.Project information up-grade ThermoFisher 9.2 to 11.1

b.Lab 4.0

i.Project information Lab automation equipment: HPLC, G.C., balances, etc.

c.Atlas to O.L. upgrade

i.Project information- Atlas to OpenLab with integration Sample Scheduler, Integration Manager

d.DCM SM Implement

i.Project information- Implement S.M. & SMIDI in all Dow Coating Material business sites.

e.SampleManager 12.2

i.Project information- Develop/ discover box functionality to reduce or eliminate customizations: ResTXT, Integration Manager, etc.

f.Tarragona O.L. Upgrade

i.Project information- O.L. & S.M. upgrade

g.SampleManager 11.1 Job Aids

i.Project information- Updating S.M. Job Aids for how post-SampleManager 11.1 upgrades.

h.Develop 21 C.F.R. part 11 documentation for and Training requirements for the team (s).

Abbvie

Aug 2016 to Apr 2018

Validation Lead

Perform system validation and quality control and ensure the system meets business requirements for lab automation

oRobotic equipment

Hamilton Plate

Protein Maker

Tecan

HPLC

NanoDrop

Bar Code printers

Bar Tender

oERP system (Oracle)

oStarLIMS

Setup and organize the structure for Gene Team

Develop code for StarLIMS and SDMS

Ensure best practices are meet

21 C.F.R. Part 11

ogenerate,

Configuration and data mapping between Genedata and StarLims

oELN

oAudit internal and External Vendors and processes to ensure compliance.

Developed Project Plans, Infrastructure Qualification Plans and managed to build out the team.

Served as a Validation S.M.E. resource within the project team and advised software projects.

Assured all Process was set to industry standards for 21 C.F.R. Part 11

Acerta

Aug 2015 to Jul 2016

SME IT/QA

Perform system validation and quality control and ensure the system meets business requirements.

Developed S.O.W. for client Q.M.S.: Veeva, Track Wise, Pilgrim:

oThe selection chosen was Veeva: Lead team to create and implement Veeva.

Developed Project Plans and Infrastructure Qualification Plans and managed to build the team.

Worked with local government and facility management to ensure all deployed systems were within applicable codes and regulations.

Served as a Validation S.M.E. resource within the project team and advised software projects on quality planning, Interpreting, and communicating compliance requirements.

Primary systems worked with; HVAC, Power Generators, PDU, Electrical, and general Network Equipment

Assured all Processes were set to industry standards for 21 C.F.R. Part 11, etc.

Approve Validation Deliverables

Facilitated Empower and NuGenesis validation projects, ensuring compliance with 21 CFR Part 11.

Authored validation deliverables for multisite deployments, including system test plans and traceability matrices.

Conducted supplier and internal audits to verify NuGenesis and Empower systems compliance with regulatory mandates.

Work with S.M.E., I.T., and Q.S. to create S.O.P., User Requirements, Functional Specifications, Designs, Validation Plans, System Tests, I.Q., OQ, Unit Testing, and User Acceptance Testing

Pre-Approve Change Requests

Approve Production releases

Perform Supplier Audit and Qualifications

Perform Internal Systems Audit

Provide Metrics to Management

Primary systems worked with; Supply Chain, sample accountability, clinical trials, PeopleSoft, document management, and Labeling systems

Systems/ Development/ Implementation Platforms; SAP, S.A.S., Oracle, Dot Net, Documentum JAVA, Access,

Servers; Windows, HP, AS400, and UNIX

Tools: Share Point, Windows Platform, Access, Visio, MS Project

Methods: Agile, Extreme Programming

Tools: Windows Platform, Visio, MS Project

Methods: Agile, Waterfall

EDUCATION

AS Math & Science; CCCC, Barnstable, Ma

BS – Biochemistry; University of Massachusetts Boston, Ma

P.M.P. Certified

Prince 2 / ITIL Level 2 Certified

Six Sigma Green Belt / Kaizen Trained

Extensive knowledge of regulations, protocols, and procedures.

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