Quality, Lab technician, Supply Chain Inventory Control

Stan Rhone 818-***-****

Barnard Street

San Diego Ca, 92110

Professional Summary:

● 6 years’ experience Quality, Quality Management systems six sigma, Gemba Improvement techniques, and over 10 year’s government-regulated experience in manufacturing.

● Roles include Quality, Quality Document Control, Lab Roles, Analytical Chemistry, Liquid Chromatography ( HPLC ), Toxicology Synthetic testing, MRB Inventory Coordinator,, and Logistics, FDA labelling, all positions compiled in a Bioscience Pharmaceutical, and Medical Diagnostic Device environment.

● Professional with the ability to work under pressure with excellent interpersonal & creativity skills, communications skills, problem-solving approach, analytical skills, time management, and technical entry skills.

● Demonstrated excellence in service following SOPs, LMS, utilizing cGMP, QMS, CAPA investigations, deviations, initiate quality Non-Conformance Reports (NCRs), and proven to be a highly resourceful team player.

● Professional, highly organized, take initiative, energetic, flexible, self-motivator, trustworthiness confidentiality skills pays key eye for attention to detail and prioritizing the tasks as per requirements accelerated as a quality associate.

● On the Quality team, performed as a visual inspector, and a coordinator for the Material Review Board.

● With the support of the quality engineers, document control was able to accomplish & deliver using the resources available, to implement, and coordinate a process that leads to a new high standard. It illustrated the importance of being compliant with government regulations.

● Experienced leadership and supervisory skills written standard operating procedures for multiple companies to successfully support their product FDA certification and ISO certified. Collect data, generate reports, for site metric development support.

● Utilized best practical process improvement (PPI) methodologies.

● Improvement measures analysis to increase in performance, decrease variations, and help improve quality. Technical Skills

● Microsoft Word

● MS Excel

● JD Edwards

● SAP Mapics

● Software courses through Workshop

● ExecuTrain

● MS PowerPoint Level 1 and 2

● MS Access Level 1 Pivot Tables Excel

● Charts and Graphs

● Advanced Formulas

● Visio 5.0

Education:

● Apics extension Course

University of California, Santa Barbara

● Graduate

Newbury Park High School

Seminars/ Classes:

Keys to Success - Los Angeles Convention Center Inventory management control, Import, export Professional Experience:

Bio Edge Oct 2022- July 2023

Chemist 1

● Characterize polymer size by GPC/SEC chromatography using established standard processes.

● Characterization of polymers by HPLC/FPLC using established standard processes.

● Daily processes include a variety of duties from monitoring freezers temperatures, Calibrating pH meters with conductivity standard, testing Deionized water.

● Optical characterization of the polymer dyes including measurement of absorbance and fluorescence emission spectra.

● Sustained personal SOP training records up to current date.

● Assisted in Capa Investigations.

● Distillation support, operate Karl Fisher Titration used to coulometric traces of water in sample testing.

● Manage dissolving, and the pouring by grams, weight into flasks.

● Acid/ Base responsibilities.

● Utilize the Viscosity Machine for testing of the Phema, Dye samples.

● Perform small scale dye labeling reactions according to established standard processes.

● Visual inspection.

● Trained new employees.

● Refractometer testing.

Thermo Fisher Scientific (Contract position)

Quality Document Control Dec 2021 - June 2022

● Manage organize and maintain GMP documents: vendor files and project associated files (e.g. batch records, testing records, validation records, and other documents as applicable)

● Ensures efficient processing of document and change management systems for the Quality Management System.

● Maintains Document and Part Number Master List to ensure proper document identification.

● Maintain, manage a comprehensive filing system and computer database for all documents to be retained in the document center.

● Batch record issuance in support of manufacturing needs, equipment, and product validations, and research and development projects.

● Check documents for adherence to the template, appropriate referencing, and good documentation practices and assist initiator in electronic documents

● Processes documents for issuance and provides notification to GMP staff for the training of new/revised documents

● Completes and reviews production documents in real time with strict adherence to cGMP, and safety practices follow (SOPs, MPs).

● Update and maintain Quality Assurance controlled binders.

● Manages the operation of the document control system so that all users have the latest accurate revision of appropriate documentation promptly.

Abbott Laboratories ( Contract )

Quality Control/ Quality Assurance Jun 2021 – Dec 2021

● Perform in-process and finished sample product Synthetic Toxicology testing.

● Understand how to make adulteration controls and negative controls.

● Maintenance of QC equipment functions well and calibration up to date.

● Perform stability testing and validation testing as required.

● Maintain records of laboratory activities in a professional, accurate manner.

● Operate lab equipment and conduct tasks safely, adhering to established guidelines and applicable regulations.

● Ability to work with SOPs and Batch Records.

● Knowledgeable of federal and other regulations, QSR's, ISO, and FDA.

● Demonstrate commitment to the development, implementation and effectiveness of the Client Quality Management System per ISO, FDA, and other regulatory agencies.

● Understanding of the quality and business consequences which may occur from improper performance of my specific responsibilities, including product design, verification and validation, manufacturing and testing activities.

● Perform visual inspections and monitor critical processes within compliance.

● Completes and reviews production documents in real time with strict adherence to cGMP, and safety practices follow (SOPs, MPs).

● Operation, set-up, cleaning, and sanitization of equipment and various cell culture support vessels. Thermo Fisher Scientific (Contract position)

Central Lab Operations Apr 2018 – Mar 2019

● Delivered support for various laboratories, which responsibilities include Rees, Smart-Vue AM, and PM monitoring temperature checks to cooling, freezing instruments which maintains the DNA research, manufacturing products by following documented Manufacturing Standards Operations (SOP).

● Specific task with media, buffer prep including but not limited to pH titration, osmolality adjustments, sterile filtration techniques, and aliquots.

● Yearly validation which included documentation to the thermometers to verify they are in standard operation.

● Demonstrated leadership helped Central Lab Operations, a new department take on critical roles, by decision making, cross-training with colleagues and new hires.

● Supported Gemba metric monitoring for practical process improvements.

● Supported with investigations, deviations, and quality non-conformance reports.

● Assisted scientists in making agarose gels for lab type, SSP, and R&D.

● Responsible for all incubators C02 (Known as carbon Dioxide) flow level which is essential for a control environment for T cell growth.

● Filled Oligo orders for SSP kit production.

● Completes and reviews production documents in real time with strict adherence to cGMP, and safety practices follow (SOPs, MPs).

● Prepare high quality specialized media, including buffers, agarose gels as defined in manufacturing procedures (MPs), and standard operating procedures (SOPs).

● Orders, receives, and stocks reagents, chemicals, and lab supplies to the appropriate departments while observing appropriate inventory levels.

● Operation, set-up, cleaning, and sanitization of equipment and various cell culture support vessels.

● Calibrate Luminex, an analytical instrument for calibration, and validation.

● Perform washroom activities, clean equipment, and small to large scale, used in production activities.

● Initiate quality non-conformance reports (NCRs) Train department’s deviations.

● Draft and revise documents (SOPs, MPs).

● Identify, recommend, and implement improvements related to Gemba routine functions.

● Assist in the review of documentation for assigned functions (equipment logs, batch records)

● Train individuals and departments proper procedures and departments on deviations.

● Utilizes laboratory equipment such as scales, glassware, and pH meters to perform measurements.

● Operates and maintains steam autoclaves, keeping records of loads completed, and items in loads. Amgen, Pharmaceutical (Contract position)

Logistics Technician Oct 2015 – Jan 2017

● Consistently performed standard operation procedures and department policies.

● Supported manufacturing for the fill of vials, and syringes on the logistics side of production.

● Utilized technical data provided to prioritized, and strategized the supplying, transportation, which included securing sterilizing of indirect, and non-direct materials associated for production products required for the scheduled dates.

● Working in clean rooms, airlocks that are air temperature controlled, clean room gowning from level 1 up to level 5 required strict adherence to current good manufacturing practices.

● Generated and documented, validated, and completed all forms accurately with the necessary calculations within procedures.

● Associated tasks included verifying, and completing transactions in SAP of incoming materials.

● Visual inspection of vials, syringes for foreign objects within the material packaging.

● Responsible for incoming time temperature sensitive compounds, acids chemicals which also included inspection validation visualizing batch records, dates codes, expiry dates, SAP material numbers.

● 97% rank accuracy level in non-requirement training in SOP in the LMS database.

● Sustained a 100% accuracy level of SOP training in the LMS database required by the due date.

● During company quality audits, as well as FDA audits kept an honest strict adherence within good manufacturing practices.

● Navigated through SAP electronic system daily, and manually sustained a filing documentation system.

● Communicated well with associates, and worked collaboratively. Zodiac Pool Systems

Quality Auditor Sep 2011 – Nov 2013

● Audited the department’s process to address document data gathered, identify the root, and cause of issues for investigation (CAPA).

● Supported the Quality team (QMS) on manufacturing outgoing freight documentation, and the assembly lines.

● Investigation generated a reason to analyse the act, revise correctly and implement a new process with higher quality standards.

● Networked with colleagues, associates so that I could contribute my efforts in simplifying, and securing production work is correct within procedure, and within Zodiacs Quality Standard requirements.

● Audits were conducted at the freight stations, or manufacturing stations.

● Trained personnel on new revised processes to help further issues or to improve on a procedure.

● All information, and audits were saved daily on excel spreadsheet for lot data history trace ability to help improvement, or implement new procedures changes.

● Responsible for overseeing, and monitoring quality processes in manufacturing, warehouse, shipment functions, and duties.

● Conducted audits on Zodiac for all outgoing shipments, and manufacturing process.

● Establish the overall quality method to determine, investigate, and resolve data quality issues

● Identify, and use opportunities to improve the quality management processes, and standards, organizational and planning skills with solid attention to detail.

● Establish an ongoing process through conducting daily audits for the quality department. Recommend modifications and possible revision changes.

● Train company department staff regarding the benefits, and need for consistent quality checking.

● Resourceful communication skills, and excellent interpersonal skills. Kavlico Corporation, Aerospace Division - Moorpark, CA Quality Associate - Aerospace Division Jan 2009 – Mar 2010

● Committed to (QMS) the responsibilities of inspection either visual, or through microscope of incoming aerospace commercial, and military raw material, and in house material to the correct spec revision levels.

● Oversaw all inspection of chemical compounds inspections for batch records, lot numbers, expiry date codes, maintained MSDS sheets, and C of C's C of A's.

● Inspection of metals through microscope for soldering, welding metals, copper brazing.

● Visual inspection of nickel plating painting to customer's specs print level.

● Obtained, maintained and documented reported all inspections rejected accepted materials, and assemblies were recorded in the computer database, and manually.

● Accompanied FAA during audit inspections.

● Promoted from MRB Coordinator to Quality support Inspection team.

● Cross-trained to learn the inspection of metals, brazing, and welding on production assemblies.

● Instrumental in assisting departments to reach company inspection goals, along with passing ISO, FAA audits. Quality team, Material Review Board Coordinator

Kavlico Corporation, Aerospace Division, Moorpark, CA Oct 2007 – Jan 2009

● Responsible (QMS ) for having the Material Review Board review, and determined a disposition for all customer returned products received into MRB, as well as making sure all product requirements are being followed.

● Once the board makes the disposition, as a MRB Coordinator enters data transactions in the system, transfers the material to the next operation either rework, or scrap.

● Purchased items received through QC inspections that were rejected turned over to MRB.

● Responsible for processing a disposition UAI, or returned to the supplier.

● Pioneered, took the responsibilities for implementing a process to have an efficiently functioning MRB Department.

● Responsible for maintaining technical data, logging data into computer, organized files, and records.

● Saved the company’s cost by salvaging parts on assembled products that were dispositional scrap, label with proper part number, and traceability to be returned to stock. Material Specialist

GE FANUC, Camarillo, CA May 2003 – Apr 2007

● Supervised, and had ownership for the Inventory department, and some production planning, production work orders expediting some purchasing.

● GE manufactured military, and some commercial electronic sub-assemblies.

● Performed downloading programming of electronic IC chips, resistors for production for soldering onto circuit boards.

● Maintained a separate master inventory of test data programmed chips to use to simplify the speed process of programming large quantities of IC chips for production.

● Utilized cGMP, ISO, and ESD training for safety to not damage product, knowledge of reading prints to locate placement of SMT components.

● Provided leadership, and illustrated excellent supervisory skills.

● Trained up to 3 employees to help maintain inventory levels of approximately 3,000 components ensuring production planning requirements were met.

● Demonstrated and guided with leadership to the production floor as well.

● Relocated 3,000+ components during a 2-day period for the company relocating from Ventura to Camarillo without affecting production, and inventory accuracy.

● Conducted daily cycle counting to sustain a high quality accuracy.

● Promoted to department lead.

● Wrote company department standard operating procedures.

● Achieved certification of department ISO audits.

Contact this candidate