Ed Smith Email & Phone Number

Port Deposit, Md, Us

Gaithersburg, Maryland, Us

• Serve as subject matter expert on computer systems validation lifecycle processes as needed. • Hold direct responsibility for qualifying computerized manufacturing PLC based systems operating within GXP environments. • Author and review computer system validation documents, including Validation Project Plans, User Requirements, and Part 11 Gap Analyses. • Manage contractors and full-time employees regarding computer system validation activities. • Drive comprehensive support of site data integrity, internal and external audits, and global IT validation and IT infrastructure teams.

Gaithersburg, Maryland, Us

• Acted as subject matter expert for computer systems validation lifecycle processes.• Held direct responsibility for authoring and reviewing computer system validation documents, including project planning, user requirements, trace matrixing, and validation reports. • Managed comprehensive system administration functions, including maintaining user accounts, audit trails, and system data storage backups. • Performed global computerized system risk assessments and vendor evaluations.• Represented EMOB on global project teams to streamline core communications and maintain consistency. • Directed a wide range of contractors, including assisting with computer system validation activities.

Lancaster, Pa, Us

• Effectively coordinated service contracts, preventative maintenance, and qualifications on LC/MS systems. • Utilized proven and demonstrated knowledge of the Mass Spectrometer software and network issues to troubleshoot concerns as needed. • Installed, setup, and configured MS software to streamline operations and core business programs. • Drove responsibility for validation process, including execution of 21 CFR part 11 compliant test plans to review and approve vendor installation and operational qualification documents. • Established functional requirement specifications for drafting IQ/OQ/PQ testing plans and standard operating procedures.

• Authored and edited validation protocols related to Pharmaceutical Quality Systems to meet and exceed cGMP guidelines. • Analyzed, created, and reviewed SOPs as needed. • Evaluated suppliers to ensure all vendors meet laboratory 21 CFR part 11 and 21 CFR compliant requirements. • Drove qualification protocols, project planning, re-qualification of protocols, and project initiation documents to review and approve for the appropriate departments. • Installed and configured performance qualification protocols as needed to streamline core operations. • Developed reporting to summarize project planning and routing for appropriate departments. • Tracked and maintained internal departmental quality systems and procedures to aid in performance of qualifications, re-qualifications, and re-validations.

• Validated protocols related to equipment, utilities, automated-systems, and processes as needed. • Authored and edited Automation Validation Master Plan to ensure 21 CFR part 11 and 21 CFR 211.68 compliance. • Held direct responsibility for installation, operations, and performance qualification protocols. • Determined acceptability of results, including generating protocol discrepancies where appropriate. • Ensured approval protocols and project plans in collaboration with fellow departments to better establish priorities, goals, and schedules of validation issues.

Responsibilities included being responsible for study set-up, coordination, execution, data collection, and data/report review of short and long-term toxicity studies (GLP and non-GLP); audited contract labs; interviewed and trained new personnel; scheduled weekly work assignments; validate computer program upgrades; assist with writing final reports; cross-trained into other groups (Histology, Formulation, Clinical Pathology, and Necropsy); writing SOPs

Us

Responsibilities included providing care and maintenance of laboratory animals and facility

Responsibilities included testing and recording data on Army test vehicles and equipment

Responsibilities included testing and recording velocity and pressure on different types of firearms; testing security doors, glass, filing cabinets, and safes for durability

Education record

Education record