SUMMARY:

• Eighteen plus years (18+yrs), Experience in Quality Compliance/Assurance in cGMP, GxP, GCP and GLP, continuous improvement processes, production floor quality reviews, process validation (CIP and non - CIP), on/off site quality vendor investigations, internal auditing processes in pharmaceutical, manufacturing/medical device industry and clinical research environments, Pharmaceutical project/program management, pharmaceutical and medical device CAPA investigations, quality engineer in medical device, biopharmaceutical and new manufacturing facilities environments, clinical data analyst, clinical project manager, regulatory global consumer complaints handling, quality review of clinical protocol binders, and laboratory scientific method analysts.
• Taught IT quality systems test writing/execution, and IT Process Project. Mgr. in clinical, pharmaceutical environment.
• Versed in the interpretation of FDA Code of Federal Regulations, including Compliance and Regulatory: ISO 13485, 21 CFR 820 Part 11, Part 58, Part 210, Part 211, Part 600, Part 610 and Part 820. Versed in OSHA regulations 29CFR Part 1910 General Industry Standards and 29CFR Part 1926 Regulations for Construction.
• Good understanding of ICH Regulations, FDA 503b Outsourcing Facility commissioning policies and procedures, and engineer validation principles.
• Strong quality and process validation background. Good project management and communication skills, excellent multi-task skills.
• Proficient medical, pharmaceutical technical writing, and investigative skills.
• Proactive approach in the absence of detailed instructions, providing progress reports to senior level on an as needed bases.
• Highly motivated to learning new processes and achieving organizational goals.

RELEVANT EXPERIENCE:

Confidential, Blue Bell, PA

Commissioning/Validation-Process Specialist/Engineer

Responsibilities:

• Perform close out Compressed Air Protocol; Close out 75-100 CAPA’s; perform Cleaning Validation activities; Amend SLIA policy; draft 2 new policies for facilities.
• Develop, Draft and/ or Revise site policy’s/ SOP(s) for client site: Periodic Review of Systems and Process; Site Validation Master Plan, Periodic Review of Systems and Processes.
• Proj Manager Lead, develop, draft policy, protocol and summary reports for seasonal execution of protocol referencing Shipping Temperature Validation Study, shipping procedures, address inefficiencies, recommended course of actions and provide an effective Shipping Program for site.
• Execute multiple test protocol, and wrote summery report for Warehouse Inspection Booths, Engineering group and Laboratory.
• Work with Calibration, Maintenance and Facilities groups to maintain all equipment information (equip #s, SLIA forms, CCA forms, work orders and due date calibrations).
• Draft / develop for the Calibration and Maintenance groups: Work Maintenance Processes and Validation of Facilities and Equipment Systems.
• Perform temperature mapping with data loggers on refrigerator project w/ lead engineer
• Create guideline template for engineering doc suppository on company’s electronic Document Control system.
• Develop engineering equipment SOP, URS, FAT, PQ Installation/Operational Qualification (IOQ) templates
• Participate in Rotation Vial Filler Equipment protocol execution for vial bottle manufacturing and write docs for proper cleaning methods
• Expose to and learned the usage of the Kaye Validation AVS equipment.
• Wrote multiple URS for the following; Laboratory Oven and Muffle Furnace Heat Units, Laboratory Spectrum equipment and wrappers for vendor IOQs summary reports, and on site Semi-Automatic and Manual Syringe and Vial filling Equipment with GPPI.
• Perform hands-on activities with Airflow Visualization and Thermal Aseptic Filling Machine with Restricted Access Barrier System (RABS) Studies.
• Perform facility inspections and review verification of system drawings (P&IDs) as required.
• Work alongside Lead Engineer, performing 1st and 2nd Smoke Study work for Vial Filler equipment; executing visual data recording, and processing collected data into reports.
• Demonstrate excellent customer negotiating and service skills, high level of attention to details, excellent interpersonal skills, effective time management, and ability to multi-task, prioritize and work in fast pace environment.
• Developed and executed the following Engineering Protocols, processes/procedures; Equipment Cleaning Process; Standardized Summary Report template, FAT template, New Product Inspection Booth, Validation of Computer and Automation Systems, Validation of Facilities and Equipment Systems, Lab Equipment Assessment (LEA) Policy and Form, Process Validation and Periodic Review of Qualified and or Validated System, Methods and Processes.
• Project Mgr. on remediated internal audit CFR 820.100. Collect/analyze data by way of SME interviews, identify and investigate cause and effect of CAPA’s, identify and write up action plan, determine root cause, write up VoE for reconciliation of Device History File(s) (DHF) for multiple CAPAs. Perform on site interviews.
• Lead auditor - reviewed/remediated CAPA’s against audit finding in the areas of DHF Binders, document control missing files, compliant files, Risk Management DFMEAs, IFU,FMEAs Finished device acceptance, complaint files, customer returns, purchasing controls, design control, preventive post market complaints, product acceptance, production process control, supplier quality systems, purchasing review and distribution activities.
• Performed investigation, root cause analysis and CAPA planning for (4) out of 16 CAPAs opened from internal audit findings were I performed manufacturing labeling activities and manufacturing scraping activities, lead meetings to collaborate with on-site engineers for CAPA remediation and DHF review. Administer In class training of company people and engineers on all new policies and procedures for Design Control (DHF). Full understanding of ISO 13485; 20 CFR 211.192; Guidance for Industry Process Validation: General Principles and Practices; GHTF/SG3/N99 edition 2; and FDA Corrections and Preventive Actions Inspection Guide.
• Created Visio diagrams(s) as one of the CAPA tools and logged all information into EtQ Reliance software. Used Citrix for offsite work; Microsoft Lync for interoffice communication and collaboration.
• Worked with engineer department to complete their CAPA remediation system documents for DHF; facilitate meetings, prepare meeting minutes and guide the project work in the CAPA system. Reviewed all Device History Files for correctness, traceability and additional remediation.
• Reviewed and worked on Risk Management CAPA; reviewed procedure for handling inspection of returned products CAPA.
• Performed/presented results of gap analysis report on corporate site documents for Design Control policies and procedures.
• Used EtQ Reliance application for CAPA processing, Action Item Activity processing, and Issue Evaluation Processing. Participated in on-site audit 12/5-12/8; prepare pre audit documentation; audit front room scribe as applicable.

Confidential, Newark, Delaware

Quality Validation Engineer

Responsibilities:

• Served as a Subject Matter Expert for CAPA, investigations and review of non-conformance of all complaint handling processes. Knowledge of FDA CFR Part 820 and ISO 13485. Provided complaint handling, quality engineering expertise and consultation to significant / complex projects.
• Lead complaint review board forums, investigations and monitor completion of tasks.
• Escalated incomplete or overdue complaint investigation and resolution tasks to management of the responsible task owner. Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions).
• Ensured prompt escalation documentation of product safety complaints by requesting feedback to regional units as needed. Ensure complaint documentation and records are complete and in compliance with all regulatory requirements prior to closure. Perform confirmed complaint trending.
• Ensure Post Market Surveillance activities are completed. Provide input on local DCU procedures and process improvements. Review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations, decisions; and write reports. Be familiar with electronic submission preparation. Work with quality system cross-functional teams, including - R&D, Product Portfolio Management, Headquarter Support, Manufacturing, and Commercial Product Quality.
• Experienced with all Siemen medical devices to know functionality for trouble shooting and laboratory testing verifications from on complaints. Participate in internal, external, regulatory review, audits, and inspections and assess, identify gaps in and update technical file when applicable. Write up resolution reports for all medical devices CAPA’s and investigations. Escalate CAPA findings and complete report to provide feedback to management
• Trained in CATs Web CAPA application; One DX CAPA Way 6-Step Root Cause Investigation Lifecycle; One DC CAPA Way Process Overview and Trained in One DX CAPA Way Documentation and Reviewer Guide. Assign user, investigator assignments in CATs Web application. Worked from home 15%

Confidential, Fort Washington Pennsylvania

Quality Validation Technical Writer, Consultant

Responsibilities:

• Reviewed 483, warning letter pre-Investigations; wrote initial CAPA reports; participated in Regulatory Inspections, manage multiple audits at one time using ATMS audit system, perform front room transcribing of audit conversations and backroom prepping of audit delegates.
• Reviewed follow-up reports from Quantic Group Observations; set up meetings to collaborate with SME’s to write and closed-out observations.
• Trained all end users on documentation GxP good practices, processes and procedures.
• Performed sustain engineering responsibilities where I reviewed blueprints, designs, created, revised and maintained technical documentation within the areas of Microbiology Laboratory, Quality Analytical Laboratory, Warehouse and Distribution, Stability, Product Development, Manufacturing Operations, Calibration and Plant Facilities (SAP). Utilize SME's, design specifications, users, system manuals etc. for guidance. Interviewed subject matter experts and all users to gather information to write a clear concise document for target audience
• Wrote SOPs and batch records in easy to read format -conveyed clearly and explicitly to remove any doubt as to what is required. Edited, proofread, and perform formatting of technical documents and trending reports for business, interoffice directors and consumers.
• Researched and determined correct documents to be developed.
• Collaborated closely with External Manufacturing Quality, Facilities Manufacturing, and Plant Manufacturing and Packaging teams to develop quality systems and report appropriate metrics. Built business relationships across multi-functional groups using strong interpersonal and communication skills.
• Worked with SME’s, future users and other authors to show how to move processes forward to completion. Demonstrated ability to facilitate work functional groups.
• Proactively identified issues and resolutions within the team. Demonstrated strong verbal, written communication, problem solving and decision making skills. Demonstrated scientific training and fundamental understanding of the product development practices, procedures and regulation. Review, interpret and make scientific conclusions and recommendations based on developmental data sets.
• Work independently, handle multiple tasks simultaneously and met critical milestones and goals. Effectively worked within a team environment and interface with peers, and management. Performed from start to finish, all document management routing process (DCM) within the Electronic Document Management (EDM) application. Worked with WERUM PAS-X software for Electronic Batch Records. Tele-commute work schedule 40%.

Confidential - West Greenwich, Rhode Island

Quality Validation Engineer

Responsibilities:

• Reviewed Info Systems Requirements and Design Specifications within Biopharmaceutical environment to determine which non-conformances and change controls implemented during the project plan phase require documentation in the Validation Summary Report (identification of the system validated, deliverables and approval dates, results obtained during testing, system limitations and outstanding issues, any deviations from Validation Plan and statement of acceptance for release of system). Reviewed Performance Qualification (PQ) test case structure data to ensure regulatory requirements are met and before release of system. Recommend and implement corrective and preventative actions where required.
• Responsible for QA oversight, quality post review, post approvals and pre review to sign-off of protocol execution. Performed close out of Functional Test Forms, and Development Test Forms. Performed quality review, processed and approval of MBR’s (Master Batch Records), performed programming in WERUM Software System PAS-X for Electronic Batch Records. . Performed wearing PPE, floor quality post review test validation and non-floor quality post review of IS test validation on project binders.
• Working knowledge of DeltaV (Emerson) Modules including unit shutdown, equipment modules, equipment sequence logic, loops and alarms & interlocks; blueprint review, generate/execute unit-level and system-level protocols for DeltaV control system per functional requirements and design documents. Performed Quality Data Reviews of documentation project binders and post approval protocol binders.
• Reviewed, validated and performed all Test Plan Specifications and Test Strategy to identify approach; wrote Test Summary Reports for 85% assigned projects. Validated graphics against Piping and Instrument Diagrams (P&IDs) requirements. Generated Traceability Matrix to verify requirements are testable.
• Scheduled huddle meetings with System Engineers and Project Managers on issues that are out of testing scope. Reviewed all incident reports and change requests for corrective documentation. Implemented required follow-up on all Change Request.
• Reviewed/performed close-out incident reports. Participated in Implementation Testing Phase to verify code matching of design and requirements.

Confidential, Fort Washington, Pennsylvania

Investigator, Label Analyst, and Regulatory Quality Compliance Specialist Consultant

Responsibilities:

• Generated from start to end, specification change controls, revised medical and non-medical SOPs, inspected and proof read packaging components (labels, etc.) for External Manufacturing/Supplier Management. Performed Change Control using EtQ application. Kept track of APR Raw Materials and Finished Product Specifications for External Manufacturing using Microsoft Excel spreadsheets.
• Performed quality control verification of bar coding for address, batch number, label defect, product number of product labeling. Report issues to supervisor. Required to stay current on FDA guidance for industry standard and drug supply. Adhered to Pharmaceutical standard glossary management when reviewing all pharma documents. Occasionally updating when applicable.
• Developed improved processes to maintain strong compliance in the assigned areas of Specifications Management, Quality Agreements, Change Control and Annual Product Reviews (API) within External Manufacturing Quality.
• Provided investigational reviews and technical reviews of Annual Product Review (APR) and researched all metric work in accordance to change control of APRs. Represented External Manufacturer Supplier and quality department at Consent Decree QSE 03, 02, 05 team training(s) and meetings.
• Wrote GMP documents. Performed SOP training, (Internal and External) quality review processes for product release, wrote product material and component specifications, participated in product reviews, wrote change controls, CAPAs, quality agreements, and investigations.
• Implemented project objective and tracked progress against timelines, provided status reports and metrics and communicated status to quality system management to ensure adequate controls are in place to meet planned commitments.
• Telecommuted work schedule 35%

Confidential, Philadelphia Pennsylvania

IQ, OQ, PQ Validation IT Analyst; Clinical Trials Informatics; Clinical Trial Data Analyst and Internal Investigator Quality Auditor

Responsibilities:

• Executed OQ, IQ, PQ, testing, developed and wrote software validation plan that demonstrated a systematic approach and contained solid findings from the projects, test cases/script for Installation Qualification and Platform Qualification while promoting participative approaches to team involvement.
• Lead on QA validation reviews of SOP and training documentation. Gathered study-specific user requirements, executed UAT task, managed project timelines and review software requirements specifications. Assessed, developed and wrote OQ Deviation Reports, OQ Risk Analysis Reports; Created and maintained “Memos to File” within clinical environment.
• Developed, monitored and managed system change control, CAPAs for compliance. Performed internal mock FDA GCP driven clinical trial audit activities and reviews. Cooperative Group Remote Data Entry activities. Evaluated software applications for functionality and usability. Clearly established project goals and objectives in the conduct of lessons learned sessions after all audits. Wrote validation documents for multiple modalities specific to clinical software in the area of radiology for Radiology Imaging.
• Provided out of box Electronic Data capture system training manual.
• Participated in the development of Interactive Response Technologies for easy to use clinical management reporting for blinded/un-blinded user groups and electronic patient diaries via the web for Confidential clinical trials.
• Monitored departmental budget, timelines, and IND submissions and provided input with budget reports and cost analysis.
• Managed and displayed productive assertiveness with project plans, keeping on track of timelines
• Conducted SOP team development meetings, ensure that quality system for GLP current good laboratory practices requirements were in place and provided cGCP regulations guideline PowerPoint training presentations and Quality Management Program initiatives to ensure proper accordance with GCP 21 CFR Part 11 regulatory requirements. Identified areas for improvement.
• Created training materials, recommended solutions, and implemented measures to improve efficiency and effectiveness of area of responsibility.
• Reviewed team medical clinical trial protocols for any GCP violations, reviewed responses from regulatory agency inspections audit reports and assisted groups with written responses and appropriate implementation of corrective actions identifying key areas of regulatory risk and suggesting potential resolutions.
• Implemented quality improvements that address weaknesses or exposures revealed through QA activities.
• Identified ways to improve compliance with regulations and company policies and procedures.

Confidential, Malvern, Pennsylvania

Pharmacovigilance /Regulatory Clinical Research Analyst

Responsibilities:

• Performed Clinical Research Project Analyst work on protocol/document reviews in accordance with SOPs, and all incoming Serious Adverse Event (SAE) forms.
• Performed accurate site follow-up for resolution of data queries and distribution of IND Safety Letters to investigators. Maintained tracking spreadsheet of all follow-up reports.
• Performed distribution, retrieval and review of regulatory documents required for initiation of clinical trials, Financial Disclosure, etc) throughout the length of the clinical trial.
• Prepared investigator grant payment requests to send to Confidential - Confidential Finance and Clinical Investigators.
• Performed electronic submission preparation. Generated periodic reports on status of grant payments and resolve all payment inquiries from investigator sites.
• Managed clinical obtained data, prepared/tracked investigational product (IP) and supplies. Tracked progress and confirmed site receipt of shipped IPS02, monitored alerts, responsible CPL whenever IPS02 inventory required review/re-ordered and assists nurse clinical research lead with drug reconciliation.

Confidential, Malvern, Pennsylvania

Regulatory Procedural Clinical Quality Control Compliance Specialist

Responsibilities:

• Developed partner relationships with Clinical Research Functional Areas (IRB, R&D, Marketing, etc.)
• Identified process gaps and compliance risks.
• Established project goals and objectives of procedural document workgroups set and managed timelines, identified milestones, assisted with logistics when functional area did not employ infrastructure staff.
• Ensured system quality in place GCP for ICH, FDA, EU directives and any other regulatory requirements, and trained Clinical Quality Compliance employees.
• Proj Mgr. to procedural document workgroups.
• Ensured ICH, FDA and EU directives and regulatory requirements were considered during procedural document development.
• Conducted Quality Compliance reviews of submission documents and assist with vendor assessment activities.
• Planned, organized and completed development of monthly procedural document metrics, and procedural document control, review, and updates.
• Represented Clinical Quality & Compliance on cross-functional teams during meetings. Provided cross-functional internal and external communication to support development and maintenance of relevant documentation, applicable to SOPs, job aids and guidance documentation.
• Provided monthly procedural document metrics.