Amy Lineberry, Cpip, Mba Email & Phone Number

Fishers, Indiana, Us

- Owned Validation Projects and was interim supervisor for validation group during management changes- Authored and executed facilities, utilities, and equipment validation protocols (such as autoclave, bioreactor (Fermentor), portable tank, Warehouse, etc )- Authored SOPs at site level and corporate level- Maintained VMPs at a site level and corporate level- Lead for Validation Weekly Team Meetings- Managed TCU Remediation Project for over 30 units - Managed consultants and contractors supporting validation department- Provided consistent validation support for the manufacturing site and completed deliverables through periods of transition, including mandatory work from home and hybrid on-site plans- Supported regulatory audits and quality documentation responses- Worked in back room for multiple regulatory inspections to expedite auditor requests- Presented information to regulatory inspectors to address requests- Successfully delivered all Audit actions on time for regulatory audits- Authored Quality management documentation including Change Controls and CAPAs, including CAPAs to address Health Canada Inspection Observations- Trained in Quality Deviations and authoring deviations- Validation and advanced user experience in eQMS and computerized systems- MasterControl Document Coordinator for the Validation group- Power User in KNEAT for Validation Lifecycle documents- Validation End User for Blue Mountain RAM system

Toronto, Ontario, Ca

Document CreationSummit, KY (November 2019 – February 2020)- Authored commissioning and validation protocols - Authored SOPs for inspection booth, flow hood and various pieces of equipmentPfizer, Sanford, NC (April 2019 – November 2019)- Authored Change Control for autoclave validation updates- Authored and executed autoclave validation protocols - Authored updates for Site Impact Assessments for utilities- Assisted with Riboflavin spray coverage testing- Reviewed ETOP packages

Hatboro, Pennsylvania, Us

- Conducted interviews of possible new hires: W2, full-time, and 1099 employees- Reviewed timesheets and invoices for discrepancies- Authored, edited and reviewed internal SOPsAjinomoto, RTP, NC (October 2017 – November 2018)- Managed validation activities for the E-7 Expansion project- Authored VMP for E-7 Expansion project- Authored IQ/OQ protocols and final reports for Purification equipment- Managed E-7 instrument and equipment list for validation

Long Beach, Ca, Us

Catalent Pharma Solutions, RTP, NC (Feb 2016 – Aug 2017)- Managed multiple projects on the site: protocol preparation, scheduling, protocol execution, analyzed data and composition of final reports- Authored and executed URS, IOQ, PQ and summary reports for various laboratory equipment- Agilent 1260 & 1290 HPLCs w/ VFD, ELSD, RID, Beckman Coulter PA 00 Plus, Hamilton STAR Liquid Handlers, Avatar FT-IR Spectrometer with OMNIC Ver 6.1a, Dionex ICS-5000+ - IC System, Protein Simple iCE3 Analyzer- Authored and executed qualification documents for Gettinge ISOTEST IsolatorFujifilm Diosynth, RTP, NC (Jan 2016 – Feb 2016)- Created item specifications for raw materials and consumables for new process- Authored and executed qualification documents for Caliper LabChip GX II SystemGSK, Zebulon, NC (Dec 2013 – Jan2016)- Managed data in LabVantage R5.2 for release and stability studies of new respiratory products- Familiar with Root Cause Analysis/Investigations Process; assisted with data analysis for investigation testing- Authored Process Validation documents and summary reports for new respiratory products- Authored deviations for validation & technical testing; involved in troubleshooting for investigations- Familiar with formatting and data required for sNDA submissions- Authored Technical Reports, summaries and Cleaning Validation documents for both respiratory and tablet product development- Managed data for Content per Blister, Emitted Dose, Aerodynamic Particle Size- Distribution and various other laboratory tests- Familiar with JMP, LabVantage R5.2, blending equipment, blister filling line equipment and assembly/packaging equipmentMerck, Durham, NC (April 2013 – Dec 2013)- Authored Decommissioning protocol and final report for site server- Authored Requirement Specs and Requirements Traceability Matrix for RtReports- Managed document review and approvals in Midas electronic document system (EDS)

Research Triangle Park, Nc, Us

Mallinckrodt, Raleigh, NC (January 2013 – April 2013)- Authored IQ protocols for new/upgraded equipment- Created forms for asset management and PMs in MaximoFujifilm Diosynth, RTP, NC (2012 – 2013)- Authored Engineering specifications and Validation protocols for new Bio-Rad Chromatography Columns and associated control console- Attended/Executed FAT for Bio-Rad Columns- Authored and executed validation protocols for Freezers, Refrigerators, GE (AktaProcess) LPC Skid, Filter Integrity Tester and Incubator ShakerAjinomoto North America, Inc, Raleigh, NC (2010 – 2012)- Served as the Quality Management Representative for ISO 9001:2008 Certification Process- Authored IQ, OQ, PQ, PV and CV protocols for Fermentation, Separation, Purification & Mixing/Packaging areas- Authored addendums and supplements for Programmable Logic Controller (PLC), Distributed Control System (DCS) and Human Machine Interface (HMI) protocols- Developed Excel Template for Homogeneity Study – multiple worksheets with calculations for individual drum samples tested

Indianapolis, Indiana, Us

- Developed and executed Media Prep, Cell Culture and CIP Skid Test Plans- Assessed DeltaV processes and screens for test plans executed- EIM/CQM (turnover package) assembly and review for Fermentation, Purification and Utilities- Development, Execution and Final Report close out of Commissioning Test Plans for Seed Train, Cell Culture and Purification areas- OQ, PQ, CV development for Dispensary & Production Support - Authored Final Reports for Production Equipment- Assembled final reports for BMS protocols- Optimization of and acid elimination from validated CIP cycles using DeltaV: reduced cycle time, amount of chemicals used and total water usage- Validation protocol development, reports and special projects- Assisted manufacturing associates with execution, troubleshooting and determination of path forward for validation protocol executions- Trained manufacturing associates to perform validation protocol execution- Assisted with revisions of SOPs and batch record revisions- Data entry, manipulation and graphing in Aegis Discoverant software- Managed, developed and executed validation protocols for laboratory equipment- Performed Maximo System data retrieval- Commissioned and validated conveyor and bi-flow table for filling line- Involved in commissioning and IQ/OQ/PQ execution for water systems- Assisted with determination of contamination root causes- Revised job plans to support system improvements- Assisted with implementation of continuous improvements to manufacturing operations- Ran in-house passivation on Cell Culture equipment (set up cycles and monitored with DeltaV)- Collected and assisted with management of CV samples through LIMS software and associated paperwork- Performed optimization of cleaning cycles: used DeltaV trending and Historian to reduce cycle times- Wrote and executed OQs for portable vessels, fixed vessels, bioreactors and temperature control stations- Commissioned HVAC systems

New York, New York, Us

While at Wyeth I learned production processing and validation requirements. I also assisted in managing samples, writing reports and other aspects of Cleaning Studies and Cleaning Validation. I helped with sampling and cleaning requirements in every production area. I also complied information and completed a filter validation project.

Woonsocket, Ri, Us

I served as a Service Associate, Certified Technician and Inventory Specialist while working at CVS. I reduced the special orders by ensuring that inventory was received from the warehouse. This saved time and costs for the location. I also resolved insurance issues and served the customers.

Master Of Business Administration - Mba, Business Administration And Management, General

Bachelors, Pharmaceutical Sciences

Certificate, Iso 9001 Lead Auditor Training

Risk Mapp Training Conference

Certificate, Biopharmaceuticals

Certificates, Pharmaceutical Training