Jaala Newby
Fuquay-Varina,NC
Summary
Career Summary: To secure a position within the pharmaceutical industry and continue to gain technical knowledge while simultaneously implementing experiences from previous positions in a way that adds value to the industry.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Upstream Manufacturing Technician I
KBI Biopharma
07.2022 - Current
- Daily sampling
- Media load into 20L wave bag, 50L, 500L, 2000 L bioreactor
- Pre-Inoc Sampling
- Inoculation
- Aseptic cleaning of hood using regulated solutions
- Aseptic Assistant of BSC activities
- Manufacturing review of batch records with Quality Supervisor
- Training MA I/II of daily task and responsibilities
Downstream Biopharma Technician III
FujiFilm
08.2021 - 07.2022
- Perform Clarification Process using pod filters, sortorous 0.5 filters and 2500L mixing vessel
- Perform Affinity process: Setup, Buffer Priming, Buffer Load, Inactivation Hold, Elution Hold
- CIEX and AIEX: Column processing, Elution, Component Test Load and Chromatography Processing
- TFF: WFI Flush, HF Integrity Test
- Equilibration, Dilution Concentration, AIEX Elution Transfer
- Diafiltration
Bioprocessing Technician IV
Pfizer
01.2021 - 08.2021
- Gene Therapy Downstream Bioprocessing Tech IV
- Startup team for new Gene Therapy Operations
- Assist in Validation and Calibration of new equipment.
- Writing and revising SOPs of Viral Filtration System
- Redlining and implementing Change Control MBR
- Aseptic Cleaning on daily, weekly, and monthly rotation per SOP’s
- Assisting colleagues in daily operations where needed
- Maintain proper documentation such as training records, batch records, check sheets, and electronic logbooks in a way that adhered to cGMP
- Served as point of contact (Liaison) and subject matter expert for downstream department for technology automation, supply chains, quality, and engineering groups as necessary.
Downstream/ Buffer Prep Lead Manufacturing Associate
KBI Pharmaceuticals
11.2017 - 01.2021
- Operating, monitoring of controlled equipment, Chromatography columns/AKTA Ready systems by way of Unicorn/ Delta V
- Solution Preps with PH/ conductivity adjustments
- Ordering of BOM (Bill of Material) Items/kitting/room readiness
- Operations of Starto integrity tester
- Aseptic sampling per client request: Bioburdens, Endotoxins, PH/Conductivity
- Executed Bulk-fills per SOP and Batch Record
- Train new associates on day-to-day process activities
- Review/Redline SOP/BPRs
- (Assisted Technical Writer in revision of BPR’s)
- Client relations: When coming to view operations for the day on critical activities.
Quality Assurance Auditor
Coty/ Kelly Services
06.2017 - 09.2017
- Visually inspected and tested all materials produced and/or used in production to determine if material met specifications and standards
- Audited processes to ensure quality standards are being met (to include but not limited to production lines, operators and departments
- Performed stability testing monitoring on products
- Collected and sent first production and marketing samples
- Maintained appropriate records on various products, components and production lines
- Ensure that corrective action is taken on defective products and components
- Audited outside processors and products as needed
- Audited component suppliers as needed
- Provided specifications to packaging through the packaging quality software as needed
- Effectively worked and communicated with other departments in the organization.
Manufacturing Associate I
Advanced Animal Diagnostic/ClinLab
03.2017 - 06.2017
- Evaluating the purity of cows’ milk for the presence of pus, blood, and ailments
- Perform manufacturing duties for the operations
- Washing/ preparations of glass substrates
- Spin coating of reagents to substrates
- Quality Control inspection of the coated substrates
- Mixing and assembly of glue mixtures
- Mixing and assembly of reagents
- Assist with maintenance of SOP documentation, best practices, and protocols
- Assist Scientist with improvement experiments
Manufacturing Associate I
Merck/Spectraforce
06.2016 - 08.2016
- I assembled all parts that were used in all aseptic processing
- All assemblies conformed to FDA standards
- All processing was completed in a clean room environment ranging from grade B to D
- Different automation systems were used to insure accurate and precise manufacturing
- Filter Integrity Testing
- Review and editing of SOPs
- Operating, monitoring of controlled equipment, systems
- Experience in a cGMP environment
- Provided material support & maintained equipment
- Real-time data reporting in Electronic Batch Record system
- GDP, cGMP, GLP
- Adherence to all SOPs and FDA regulation (21 CFR Part 11)
Fill Finish Manufacturing Associate 1
Novartis/Pro-Unlimited
02.2015 - 10.2015
- Conducted all assigned activities in a safe cGMP compliant manner focusing on “Right First Time”
- Cleaned, prepared, and sterilized components via Parts Prep Washer
- Cleaned and disinfected class 100 production rooms
- Assembled, set-up, and disassembly of production equipment “200L vessels, 400L vessels, component canister
- Executed process steps according to defined SOPs and BPRs
- Documented activities and review of documentation in accordance with cGMPs
- Perform Filter Integrity Test (Millipore)
- Assisted in the setup of the Isolator Filling Machine (Groinger)
- Handled biologically and chemically hazardous goods
- Advanced understanding of process automation systems and advanced user of electronic business systems (PAS, BAS, PLCs, LIMS, SAP, LiveLink)
- Supported team with root cause investigations and CAPAs
Quality Inspector
GKN, Randstad
11.2013 - 10.2014
- Learned and developed hands-on proficiency with composite inspection processes utilized by the company
- Performed inspection activities involved in the manufacturing of products and processes
- Followed written and verbal instructions, engineering drawings or sketches
- Participated in the operation of and compliance with all safety, hazardous material handling and disposal requirements in accordance with government regulations and company procedures
- Performed Process and product audits
- Prepared inspection reports, document observations such as non-conformances
- Maintained a clean work environment (including assigned storage and cleaning duties) in full compliance with all internal, customer and government regulations.
Education
Associates of Applied Science - Biopharmaceutical Technology
Wake Technical Community College
Raleigh, NCAssociate of Applied Science - Medical Laboratory Technician
Sandhill Community College
Southern Pines, NCSkills
- Programming/Software Skills
- Microsoft Office, SAP, LIMS, Unicorn, Delta V, ETQ/Compliance Wire, Blue Mountain, Trackwise, Master Control
- 20L Wave bag, 50L, 500L, and 2000L Bioeactors
- Vi-Cell and NOVA- BGA
- Tangential Flow Filtration, Hollow Fiber Tangential Flow Filtration, Nanofiltration, Depth Filtration, Akta Pilot, Akta Ready, Pre-packed column from 1L-100L, Single Use Mixing System (Pall and GE), Single use connectivity such as GE, DAC, and AseptiQuik, BSC
Certification
Phelbotomy, Btech, BioWorks, Medical Secretary, Advance Downstream Course
Timeline
Senior Upstream Manufacturing Technician I
KBI Biopharma
07.2022 - Current
Downstream Biopharma Technician III
FujiFilm
08.2021 - 07.2022
Bioprocessing Technician IV
Pfizer
01.2021 - 08.2021
Downstream/ Buffer Prep Lead Manufacturing Associate
KBI Pharmaceuticals
11.2017 - 01.2021
Quality Assurance Auditor
Coty/ Kelly Services
06.2017 - 09.2017
Manufacturing Associate I
Advanced Animal Diagnostic/ClinLab
03.2017 - 06.2017
Manufacturing Associate I
Merck/Spectraforce
06.2016 - 08.2016
Fill Finish Manufacturing Associate 1
Novartis/Pro-Unlimited
02.2015 - 10.2015
Quality Inspector
GKN, Randstad
11.2013 - 10.2014
Associates of Applied Science - Biopharmaceutical Technology
Wake Technical Community College
Associate of Applied Science - Medical Laboratory Technician
Sandhill Community College
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