Technical Writer / QA Specialist - Lonza AG - Remote
(2022-08)
- Write and revise manufacturing documents, Master Batch Records, Component records, and Formulation (Buffer) records according to relevant BFDs (Batch flow diagrams) and BOM (bill of materials)
- Works in TrackWise for track and trend and deviations and change controls
- Serve as the primary advisor for documentation to Cell and Gene Therapy Clients and Viral vector sectors
- Implement EPS (Error Prevention System) to batch record templates
- Partner with MSAT scientists and Manufacturing staff to develop user-friendly batch record templates
- Collaborate with the client on document review and approving them
- Working on the DMS system software (Document Management System) for reviewing and revising documentation
- Offer suggestions to improve the document format to make the documents more usable to the target audience
- Provide assistance and advice to internal customers on using the Electronic Document Management System
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures, and instructions for all activities in which the team participates
- Perform other duties as assigned
QA Operations Specialist - Catalent Pharma Solutions
(2021-04 - 2022-08)
Quality Assurance operations role responsible for sampling, batch record review, QA floor tasks, and regulatory compliance.
- Performed assigned sampling tasks to standard operating procedures
- Review Raw Material Packets and release them to Production, Manufacturing, and QC
- Batch Records Review and further documentation aseptically
- QA on the Floor tasks
- JDE Software, ETQ software usage on daily tasks
- Works in TrackWIse for track and trend and deviations and change controls
- QC batch record and testing record review daily
- Assigned the Lot numbers to the manufacturing department for their daily runs
- Ensures compliance with all regulatory agency requirements and company-specific regulations related to product quality
- Review records to ensure they are complete, accurate, and compliant with current Good Manufacturing Practices (cGMP) requirements. Forms include batch records and other documents involved in the manufacture of drug products
- Reports errors, deficiencies, discrepancies, and observations to management. May stop operations when product safety is or may be compromised
- Performs Quality functions in classified areas, including checklists, aseptic intervention oversight, and line clearances
- Develops and trains others on new material specifications upon request; revise existing material specifications when necessary
- Works with the management team to prepare for internal and external auditors. Assists with timely closure of audit observations
- Lead monthly/quarterly quality assurance audits for critical logbooks and required inspections of classified areas
- Track the progress of documentation associated with Quality Events, including but not limited to investigations, deviations, material review board, change control, specification, and corrective action/preventative action (CAPA)
- Initiates standard operating procedure (SOP) revisions to support continuous improvement
- Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation
- Monitors operational processes by performing product changeover/room clearance inspections and auditing work-in-progress, then reporting results to proper management
Quality Specialist - iBio CDMO, LLC. - ALKU, LLC
(2020-08 - 2021-02)
Quality specialist role focused on sampling, batch record review, quality events tracking, and microbial monitoring in aseptic environments.
- Performed assigned sampling tasks to standard operating procedures
- Collected routine EM samples in ISO-classified clean rooms. Sample types include air-viable, surface-viable, and air-non-viable monitoring in the aseptic environment
- Make sure that the microbial data in the documentation has growth within the specified limit and procedures were performed aseptically
- Perform batch record review and disposition activities. Batch record review consists of executed batch records, all associated Quality data, review of associated Quality Events, and disposition to meet pre-defined timelines
- Track the progress of documentation associated with Quality Events, including but not limited to investigations, deviations, material review board, change control, OOS, and corrective action/preventative action (CAPA)
- Sampled purified water system for analysis for Bioburden, TOC, Conductivity, and Endotoxin
- Maintained and recorded data clearly and precisely on quality documentation
- Performed Appearance testing of finished product vials
- Performed microbial characterization and presumptive testing
- Inventory Management of EM supplies
- Identify and communicate quality or compliance risks associated with a manufactured lot and coordinate a plan to address risks
QC Chemist / QA Specialist - WDPrx
(2019-03 - 2020-08)
QC Chemist and QA Specialist role involving testing of raw materials and finished products in a GMP environment, instrument operation, calibration, and documentation management.
- Testing Raw materials and finished products like syrups and suspension in a GMP environment
- Run instruments like HPLC, GC, FTIR, Karl Fisher, etc.
- ICP Analysis of Heavy metals to some extent
- Daily calibrations of balances
- Documentation assigned to the work tasks. Track documentation progress associated with Quality Events, including, but not limited to, investigations, deviations, material review boards, change control, OOS, and corrective action/preventative action (CAPA)
- Other duties as assigned by supervisor from day to day
- Reviewing Batch Records like MBR and PBR
- Scheduling the instrument PM
- Helped with the Stability Data Review and monthly pull schedule
- Calibrate the instrument according to the SOP
- Writing Protocols according to the cGMP environment
- Performed Performance Qualification of HPLC according to established Protocols of Thermofisher Scientific
- Temperature monitoring of the whole facility in Dickson One software
- Scheduling the Performance Maintenance/Service Request service of Instruments and Pipettes and documenting the paperwork
Lab Technician - Accexx dx lab / Memorial Hermann Diagnostics Laboratory
(2018-08 - 2019-01)
Lab Technician role involving patient registration, documentation, logging, data analysis, and toxicology testing.
- Registering Patients in 2 LIMS Systems in the nighttime shift
- Did documentation involve in CLIA/COLA Inspection
- Maintained all logs involved in the lab
- Data Analysis on Shimazu Instrument
- Run Urine Tox samples in Mindray Analyzer and Confirmation on Shimadzu 8050
- Compiling paperwork and sending them back to different departments
Lab Technician - Quest Diagnostics via All Medical Personnel Staffing
(2018-02 - 2018-07)
Temporary assignment in fast-paced Microbiology department.
- Worked in a fast-paced Microbiology department
- Worked on Setups of Micro scan prompt patient samples and Vitek -2 of the patient on an instrument
- Performed all other duties as assigned
Clinical Scientist - Select Laboratory Partners
(2016-07 - 2017-12)
Clinical Scientist role performing medical laboratory tests, procedures, and analyses on clinical specimens for diagnostic purposes. Experience with multiple analyzers and confirmation instruments.
- Routinely performs medical laboratory tests, procedures, experiments, and analyses to provide data on clinical specimens for diagnostic purposes
- Records have known control values from technical instruments to ensure reliability and accuracy in test results reporting. This includes experience operating the IR-500 Analyzer, MindRay-4080 Analyzer, and Confirmation instrument Shimazu, doing Extraction, and running patient Urine samples. After that, Analyze Data on the Confirmation tool and report after the successful completion of processing
- Making Mobile phases, Reagents, and tracking the Inventory of both instruments
- Documentation and Maintained Lab. work
- Worked on laboratory safety protocols, QA Manuals, and SLP LIS software
- Data Entry of Patient information in Select Soft LIS Software and arranged Documentation of requisitions and reports of Patient Samples
Sr. Lab Tech / PRN - Houston Pain Center / Elite Medical Lab
(2013-04 - 2016-06)
- Toxicological analysis of urine samples under high complexity
- Routinely per
