Anthony Smith
Cameron,NC
Summary
Extensive experience in Pharma Biotech Production and Manufacturing Facility Operations. Consistent history of consistent business work ethics, Pharma Operations, FLQA, R&D QA, Mechanical and QS skills. Training and implementation of effective teamwork among coworkers. Strong project, training, and leadership skills. Multitasking and cross-training for multiple production areas to meet business needs. FLQA/R&D QA and QS batch record reviews and all support functions. Manufacturing experience in Upstream, Downstream operations in Purification, Fermentation and Filling. Commissioning, Validation and Protocols. FLQA Production BPD review, Work Orders, SAP, Fill Finish, Disposition, etc. Excellent verbal and written communication skills. EM sampling of WFI and clean steam. Manufacturing Quality Systems experience with deviation reports (DR), CAPA, PTC’s and Investigations. Aseptic production applications include aseptic fills of finished products and media sim processes.
To obtain a position that challenges all my professional background experience within the industry with opportunity for advancement, developmental skills and process improvements. Ability to successfully meet and exceed all expectations, goals, and objectives in the position. Accomplish all business needs for both customers internally and externally successfully with Quality products for patient care and great customer services output.
Overview
32
32
years of professional experience
Work History
FLQA Specialist I/MFG Quality Systems Specialist/ R&D Release
Seqirus
10.2015 - Current
- R&D QA batch and material release, Specifications and Quality Document builds, WO’s, IA’s, EA’s, Change Notifications, SAP builds, SAP release Raw materials, batch disposition functions, etc.
- FLQA functions Fill Finish, Bulk. Formulation, Filling, Weigh and Dispense, Packaging, Labeling, Manual Inspections, AQL, Line Clearances, etc. EM sampling WFI and Steam. BPD reviews for disposition and work order approvals in SAP
- Investigations, Deviations, CAPA’s and Product Technical Complaints (PTC’s). BPD reviews and page reprints in real time. Floor support, review and real time resolutions for any production issues.
- Fill Finish Expansion Project with new facility start-ups, approval of documents, WO’s, etc.
Manufacturing Science and Technology (MS&T)
Pfizer
01.2013 - 01.2015
- Purification, Chemistry, and Fermentation support for production batches in scale up labs. Assisted with work orders, PM’s, Buffer Prep, and CIP solutions and other process needs
- Point of contact for Safety Operations during equipment processes/CAPA implementation
- FLQA/QC reviewer, Disposition, Documentation review for production records as needed
- Primary contact for work order maintenance in area and equipment set-up and operations
Clinical Trial MFG Manufacturing Associate IV
Pfizer
01.2011 - 01.2013
- Compounding Buffers / Weigh Out Raw Material and release for production
- Team Lead Purification Group, CTM material start up, QC/FLQA processing data review
- Revise SOP’s, Master Batch Records (eMBR), and Compound Records
- Team Lead tasked with meeting production schedules and adhering to safety at all times
- Delta V, HMI, HPLC, FAT’s, Process Overviews, COA’s and Production Flow improvements, etc.
Manufacturing Associate IV
Pfizer
01.2010 - 01.2011
- Implementation and cost reduction projects within several manufacturing areas
- Cross training, OJT trainer for departments for training as needed
- Bio Technician IV Manufacturing Production operator and rotating shift work
- Team Leader tasked with meeting the production schedules and adhering to safety at all times
Quality Assurance Area (QA Specialist I)
Pfizer
01.2007 - 01.2010
- Investigations, Deviations, IQ, IOQ, PQ, PV, DCE’s, CC, PPQ, FAT’s, Delta V, etc
- Executing Quality systems SAP, LIMS, Veeva, Trackwise, MES, Sentry, etc.
- FLQA floor support real time review of BPD’s, Revised SOP’s and BPD records
- Review and Disposition of BPD’s, Buffer records, and other Production Records
- Review COA’s for raw material approval, WFI/Clean steam release, DCE’s
Manufacturing Associate III
Pfizer
01.1998 - 01.2007
- Support production for Purification/Fermentation/Media Prep/Parts Prep
- Execute Critical Set-Up parameters and tolerances for startup of new facility with Delta-V
- Meet production schedules with Quality products for internal/external customers
- Support startup activities of new automated manufacturing areas (HMI, Delta-V, etc.)
Shipping and Receiving Clerk
Pfizer
01.1996 - 01.1998
- Stability sample retention, Stocking, Inventory, Inventory Control, and Distribution
- Fill in lead position when needed, Cold Storage Management, Loading Shipments
- Sampling Raw Materials, Hazard Material Control, Forklift maintenance checklist
- Bulk Shipping/Packaging/Receiving, Raw Materials Release and Quarantine
Manufacturing Associate I
Pfizer
01.1994 - 01.1996
- Production and Inventory of finished goods and transfer to warehouse storage areas
- PM/Mechanicals / Equipment Care contact, Maintenance contact for PM’s
- Executed calibrations and tolerances of critical parameter equipment used for production
- Sampling Raw Materials and Finished goods for release or quarantine status
- Tablet and Oral suspension batch production operations
Education
BS degree Engineering - Quality Control and Quality Assurance
Warren National/ Kennedy Western University
01.2007
Skills
- Quality Assurance includes Veeva, SAP, LIMS, CAPA, DR, Trackwise, Success Factors, WFI/CS release, MES, etc Investigations and resolutions for “on hold” or “quarantine” batches
- Manufacturing includes years in FDA/cGMP facility, extensive background in several production areas that includes troubleshooting and resolution skills for equipment and processes Strong background in CIP, SIP, and Aseptic training in specific areas of production
- Aseptic Filling Operations within cleanroom environment and Media Sim operations
- Working with Engineering/Maintenance groups on equipment care implementation for PM’s, Work Orders, Maximo, SAP and Job Aid revisions in areas of operations plant wide FAT, PQ, IOQ, and OQ experience
- Clinical Trial within MS&T includes new start up processes with critical equipment, scale up labs facility including Compounding Buffers and Raw Material Weigh outs
- Extensive shipping and receiving experience, UPS, FedX, and other freight carriers (BOL’s)
- Quality assurance
- Quality assessment
Timeline
FLQA Specialist I/MFG Quality Systems Specialist/ R&D Release
Seqirus
10.2015 - Current
Manufacturing Science and Technology (MS&T)
Pfizer
01.2013 - 01.2015
Clinical Trial MFG Manufacturing Associate IV
Pfizer
01.2011 - 01.2013
Manufacturing Associate IV
Pfizer
01.2010 - 01.2011
Quality Assurance Area (QA Specialist I)
Pfizer
01.2007 - 01.2010
Manufacturing Associate III
Pfizer
01.1998 - 01.2007
Shipping and Receiving Clerk
Pfizer
01.1996 - 01.1998
Manufacturing Associate I
Pfizer
01.1994 - 01.1996
BS degree Engineering - Quality Control and Quality Assurance
Warren National/ Kennedy Western University