Senior Quality Control & Manufacturing Leader

SAMUEL FIGUEROA MARTINEZ

*** ****** ****** *** *** Deerfield Beach FL 33441

Cell phone: 954-***-****

E-mail: ********@*******.*** or ********@*****.*** Objective: Obtain a challenging position in Engineering /Quality Control / Manufacturing / Supervisor or Manager Field in which I can positively execute my years of experience, knowledge and be a great asset for the company.

Qualifications:

• Quality Control Background: Quality Control-Assurance and manufacturing processes. Experience with ISO, cGMP, Compliance, validation processes, CAPA, ISO, OSHA, FDA regulations and others.

• Pharmaceutical and medical device industry experience: Mechanic equipment expert technician, Processes, documentation, equipment, inspection, graphics and blueprint reading/interpretation, coating, compression and capsule filling, clean room environment experienced. Experience:

Maintenance Manager 8 years.

Quality Control Manager: 5 years.

Quality Incoming supervisor: 3 Years.

Quality assurance and Quality control inspector: 10 years. Pharmaceutical technician: 8 years.

Skills:

Microsoft programs: Excel, Word, Power Point

Very proficient in computer programs “PLC Allen Bradley 5000 and 5500 electronic Troubleshot cards, sensor RW AW and reed switches. Expert on “VFD”, can troubleshoot PLC with manual inputs and outputs or with laptop.

Solid Work

Auto Cad

SQ’Lims

AS 400

All Mechanic Skills

Electro Mechanic.

All Auto body and Collision repair

Fork Lift operator and trainer all kind for lift experience Certifications: Additional Trainings and Certifications

• Food Safety certified 2017

• FDA Certification-cGMP’s Batch Record Review and Failure Investigations.

• cGMP’s -Complete Good Manufacturing Practices.

• Current Good Manufacturing Practices for Drug II.

• Quality Assurance in Manufacturing Operations.

• The Formula of Drug Product.

• Biopharmaceutical Characteristics of a Drug Product.

• Technology in Manufacturing and Packaging Processes.

• Manufacturing Process Control.

• Laboratory Control.

• SOP’s Documentation.

• Lean Six sigma trained by Johnson &Johnson / Valeant pharmaceutical Company.

• 5 “S” trained by Johnson & Johnson ETHICON.

Samuel Figueroa

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Education:

ersity Ana G. Mendez”, Florida /Gurabo, Puerto Rico 2006-2009 ee

gineering technology

draulic, Pneumatic, HVAC, Computer PLC troubleshoots, Metallurgical, Solid work, Auto Cad. University San Juan, Puerto Rico 1987-1990

n in Psychology

xperience:

s Boca Raton Florida April 2024 to Jan 2026

ntenance Supervisor

s: In a Plasma medicine pharmaceutical on charge of 6 maintenance staff. I need to have: plans, organizes, and provides supervision and oversight for daily maintenance operations as well as execution of preventative maintenance activities on the Boca Raton site. Systems to be maintained include HVAC, Plant Steam, Chilled Water, Cooling Water, BMS, Clean Steam, Compressed Air, Emergency Generators, WFI (Generation, storage and distribution), and Ethanol (storage distribution). The position holder supervises and evaluates the work of ADMA employees as well as outside contractors and ensure that tasks are performed in conformance with various national and international government and health regulatory approval agencies, local and state codes, applicable industry guidelines and company policies. The position holder will be self-performing work order as part of daily performance of duties.

Essential Functions (ES) and Responsibilities

• Supervises maintenance staff by determining workloads and schedules; develops, interprets and implements policies and procedures; evaluates staff and makes hiring and termination recommendations; and ensures that staff are trained in complex maintenance activities and are following standard operating procedures.

• Provides input into the development of the operating budget for the assigned area of responsibility; orders materials and supplies; assists in the monitoring and tracking of expenditures for the section.

• Coordinates maintenance activities with other departments, including scheduling and resolving problems; coordinates and inspects work performed by contractors.

• Assists in the selection of staff; performs periodic evaluations of subordinates and recommends and implements discipline as required.

• Ensures that safety training is provided to staff and that proper safety practices are followed.

• Responds to emergencies as requested; coordinates activities with other responders; directs the work of staff and utilization of resources to effectively repair and ensure the safety and availability of the Utilities.

• Perform a variety of field maintenance tasks, PM’s and Work Orders.

• Prepares records related to the work performed and materials and supplies used; enters purchasing requests and work orders in the computerized purchasing system.

• I check for: Facilities Maintenance activities, including budget, schedule, and document management, in the design, cost estimating, procurement, installation, construction, modification, and commissioning, as applicable, of complex multi-system, multi-discipline equipment and systems for general use and GMP regulated areas. This includes biotechnology and laboratory facilities, warehouse and general, product, and raw material storage, dedicated and general service and utility areas, and building and site services, consistent with national and international government and health regulatory approval agencies, local and state codes, applicable industry, life and property loss prevention, safety, and cGMP guidelines and practices.

• Experienced in the technical operation and maintenance of Water for Injection (WFI) systems, autoclaves, HVAC systems, complex electrical and steam powered high capacity chillers and ultra-low temperature refrigeration systems, cooling towers, liquid pumping and compressible gas fluid systems including air compressors, natural gas and diesel fired and waste heat boilers, clean steam NG/diesel electric generators, decon and waste neutralization systems, Low- Medium-High voltage power switching and distribution systems, building structure and architectural systems, and life and property protection systems.

• Experience with process automation programming applications, controls/automation installation & troubleshooting, operator & equipment interfaces.

• Able to diagnose and troubleshoot complex multi-discipline equipment and systems. Perform trend analysis and engineering reliability studies on plant and building equipment, systems, and instruments. Provide recommendations to optimize operation by increasing reliability, safety, and operating and maintenance efficiency, and reduce operating costs and overall (planned and unplanned) downtime. Draft, revise, maintain and/or implement operational and preventative and/or predictive maintenance procedures and guidelines.

• Support CMMS, maintenance, and metrology personnel in creating or revising master data specifications, calibration procedures, maintenance task lists, SOP’s, and other related documentation.

• Planning and detail oriented, flexible, good negotiation and communication skills (verbal and written), ability to work well with others, and must have a strong sense of commitment.

• Must have a demonstrated capacity to work within budget to meet milestone objectives and timelines.

io Texas Oct 2022 to April 2024

ventory Coordinator E-29 Contractor

s: Work in direct parts inventory for Boeing 737 and 787.

• Performed internal audits.

• Performed city and state audits for facility aircraft regulations. Professional Experience:

Maruchan Texas Inc. San Antonio Texas Dec 2020 to April 2022 Quality Control Assistant Manager

Responsibilities: On Charge of 23 laboratory quality control techs and 10 sanitation techs at Maruchan Texas Inc in combination of (Contract by Remedy Staffing) On charge of SOP’ redaction plus SOP’s implementation. Evaluate QC process at Noodle Soup high Volume Production.

Make a distribution everyday of QC staff at different production schedule by days and hours. On charge of: Complain, internal audits, work in conjunction with Plant manager to received AIB auditors.

On Charge of quarterly microbial Samples.

Professional Experience:

El Milagro of Texas Inc. San Marcos Texas, March 2015 to Dec 2020 Maintenance Manager (On Charge of all mechanic staff) Responsibilities: Supervise a mechanic group of 8 mechanics. Make a schedule for all week PM and Daily equipment check.

• Troubleshoot any problem of malfunction in production equipment. (Electrical, electronic, pneumatic, hydraulic or mechanic).

• Prepare SOPs for each equipment. Preventive maintenance for production and waste water treatment plant.

• Report weekly plant to general manager.

• Analyze by work hours parts that need to be replace and on charge of have in stock spare parts to hall plant.

• Certified in forklift and sky lifter.

• Waste water on charge at El Milagro of Texas Daily check and PM. We fix a Lawrence equipment flour tortilla line, JC ford Chips tortilla line with (oil fryer), JC ford Corn tortilla line.

Food Safety Manager (Quality Control Manager)

Responsibilities: Food lab testing Quality control technicians. On charge of 8 laboratory technicians. Samuel Figueroa

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• On charge of final approved of in house complain investigation. train QC department for develop

complain investigation.

• June 2017, went to Chicago U.S. for obtain the FSMA (H.A.R.P.C.) training In FSPCA Facilities.

(Certified).

• Responsible of BRC audits and Mock internal audits and health state department plant visits.

• Responsible for creating and generate SOPs of food process steps.

• Work in combination with safety manager to create and implement safety procedures.

• Report to plant manager all quality control changes.

• Participate in daily manager staff meeting.

• On Charge of class room for trains the process staff.

• On charge of all SOP’s update and record.

• Knowledge of ISO 9001, 2008 changes regulations.

• Bring the company’s QAQC documentation up to date as per latest/Current FDA audits/standards.

• Further develop and implement the Company’s Quality Management Systems for FDA compliance and

Support other company units in introduction and maintenance of the cGMP’s standards’. Stay current with cGMP’s regulation.

• Bring required training of all employees up to date: keep training record up to date in food safety regulation.

• SOP creation, revision. Review and execution and filling. Professional Experience:

Johnson Controls Inc. San Antonio TX. August 2013 to March 2015 Associate V maintenance technician.

Daily production mechanic on automotive batteries manufacture company. On charge of maintenance PM.

• Wastewater tech in Lead water treatment. Check every day waste water system in car battery plant. Performed Pm on WW plant.

Prepare solution and polymers for treatment process.

• Repair conveyors, different gearbox with motor.

• Different computer systems.

• Knowledge on electric, electronic PLC 5000, pneumatic.

• Acid formulation experience gravity 1150,1320,1345,1390 Professional Experience:

Cox Manufacturing San Antonio, TX Oct-2010 to March-2013 CNC Swiss Machine Technician

Engineering Department & Deco-Manufacturing Dept.

• Responsible for the making of small precision parts per purchase orders following blueprints, procedures and quality standards for major accounts such as: US Army, US Air Force, automotive industry, Air conditioning suppliers and others in CNC Swiss Machine.

• DECO 10&20 CNC machine and equipment set up, First Article, check/monitor operation, in-process inspection and troubleshooting.

• Verification of incoming raw material, parts inspection, review of documentation, checklist completion, document review and data entry on the production (internal) system/software (Cox System).

• Reading of blueprints.

• Oasis inspection system performs inspection to different parts.

• Decontamination utilizing Vapor Degreaser for area cleaning. Samuel Figueroa

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Professional Experience:

Valeant Pharmaceutical Humacao, Puerto Rico Feb 2000-June 2009

(ICN Dutch Holdings Inc.)

Active QA incoming Supervisor/Quality Control Technician

• Incoming Area raw material sampling and dispatch. Worked in inventory with AS400 system

• SQLIM’s super user for report raw material sample to laboratory. Quality Control Duties

• Experienced in controlled substances validation and processing.

• Process inspector.

• USP WATER sampling in all points of pharmaceutical plant. .

• Approved materials for production/manufacturing.

• Assist and support other areas like: audits, documents approval, methods preparation and SOP’s.

• Worked with SQLim’s and AS400 Systems.

• Trainer in all responsibilities within ICN Dutch Holdings including monthly Compliance and Safety talks.

• One year safety committee team, training new personnel in respiratory equipment, fork lift manage, all safety area chemical MSDS, physical work. On charge to give to a QA and QC team one month safety training.

• Batch documents verification and management.

Achievements:

• Suggested and implemented ideas for accident and risk reduction in Coating Area.

• Identified humidity issues, implemented and installed dehumidifiers to obtain correct humidity parameters in QA Incoming Area, assuring accurate readings for quality process.

• Room Sanitization experience LPH, Amphyl, Sani T -10.

• Major responsibilities such as: performed inspection for Coating Area, capsules components preparation in PMA and Spheronizer equipment according to SOPs, FDA and other regulations.

• Components verification to be in compliance.

• Worked with H &K capsules filling machines and Precisa inspection equipment.

• Experience working with Accela Cota 60” and Glatt 500kg equipment’s.

• Perform quality process trainings to new hired operators. Achievements:

• Implemented the use of Checklist form in Compression Area providing operators a simple way to verify equipment were in compliance and helping risk reduction for investigations, when necessary.

• Safety manufacture change in steam valve for equipment’s. Professional Experience:

Janssen Ortho Gurabo, Puerto Rico Feb1990 – March 1999 Production and Warehouse / Act-In Coordinator on charge of 30 person Received raw material, dispatch by lot and code material for process. Report monthly inventory.

• Process Operator

• Performed manufacturing process operations in Granulation and Sift areas.

• Used with Glatt & Arcadia equipment, Accela Cota 48” Compu coat 2 and Accela Cota 60” Compu coat 4.

• Coating suspension and solutions preparation.

• Worked in creams and liquid areas utilizing turbo emulsifying equipment 1,000 lt.

• Compressing equipment use of Manesty machines such as: Mark IV and Nova Press.

• Capsule filling on H & K equipment.

• Chemical weight of active and inert components.

• TSD Certifications on: CGMP 101 and 102.

• Assisted on validations for granulation, creams, coating, production documents, SOP’s and others. Samuel Figueroa

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Professional Experience:

Astacio Pump Services Ponce, Puerto Rico Aug 1987–Feb1990 On Charge of 7 concrete Pumps Mechanic PM’ (Maintenance Manager) Pneumatic, hydraulic, diesel mechanic and supervise 8 heavy equipment operators. Additional Trainings and Certifications

• FDA Certification-cGMP’s Batch Record Review and Failure Investigations.

• cGMP’s -Complete Good Manufacturing Practices.

• Current Good Manufacturing Practices for Drug II.

• Quality Assurance in Manufacturing Operations.

• The Formula of Drug Product.

• Biopharmaceutical Characteristics of a Drug Product.

• Technology in Manufacturing and Packaging Processes.

• Manufacturing Process Control.

• Laboratory Control.

• SOP’s Documentation.

• Lean Six sigma trained by Johnson &Johnson / Valeant pharmaceutical Company.

• 5 “S” trained by Johnson & Johnson ETHICON.

References

Available upon request.

Contact this candidate