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Risk Assessment/training Sme Consultant Resume

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  • Seeking a Training Management Position wif an Innovative Corporation.


  • Training Analytical Testing
  • Trending and Data Interpretation Technical Writing Supervisory Equipment Maintenance Equipment Validations (IQ/OQ/PQ) Risk Assessments/Investigations Auditing Safety Inspections: JSA
  • OSHA
  • Bloodborne Pathogens
  • CPR Training Regulations: FDA/GxP
  • FCPA
  • CFR
  • ISO
  • Workplace Harassment Office: Word
  • PowerPoint
  • Excel


Risk Assessment/Training SME Consultant

Confidential, NJ


  • Project - based contract. Remediation for Pharma. Companies. Performed floor audits and made recommendations for process improvement and cited regulatory guidelines.
  • Designed training modules and OJTs for multi-company sites. Performed formal and refresher training sessions. Developed and facilitated Train-the-Trainer classes.
  • Simultaneously, remotely served as Training Advisor for a company in India. Reviewed proposals and made suggestions for response to FDA and training and development plan for manufacturing Supervisors, Leads, and Operators.

Corporate Training Consultant

Confidential, Houston, TX


  • Project-based contract. Performed needs assessments and made recommendations to drive multi-dept. open projects to completion.
  • Developed training modules, work instructions, presentations, OJTs and videos/video editing to align wif the priorities of Sr. Leadership Team.

Corporate Training Manager

Confidential, Sugar Land, TX


  • Design, Develop, Standardize, Implement and Manage Training for all company sites. Work wif Dept, Managers to establish training program.
  • Create User Accounts Trouble-shoot User issues in Learning Management System (Master Control), Deliver Compliance and Technical training, Design Curriculums, Perform Needs and Gap Analyses, Assess Competencies, Conduct New Hire Orientation, Process Mapping, Suggest Process Improvements, Ensure Regulatory Compliance, Create modules, technical documents, OJTs, templates, Read and revise SOPs, Initiate Change Controls and CAPAs and ensure follow-through.
  • Report Quality Metrics. Perform Production Compliance and Safety Audits, Oversee Sterility Assurance functions, Gowning Training and Aseptic Behaviors as well as Train-the-Trainer.

Sr. Technical Support Specialist

Confidential, Ft. Worth, Texas


  • Developed and Implemented all new Aseptic Processing GMP Training Program for all aseptic operators including Fill Techs, Mechanics, and Support Services, Coordinate and serve as technical presenter and Facilitator for all classes (delivered to Novartis and Alcon) as part as TOP 8 PRIORITY initiative; Serve as Senior SME for Novartis Global Aseptic Operator Certification Program, perform benchmarking.
  • Gap assessments, attend weekly global conference calls representing Fort Worth, TX site as advisor and lead for global standardization of best practices; and cleaning practices, Perform manufacturing investigations and root-cause analyses, Investigate Adverse Trend Reports, Perform Gap Assessments pertaining to Aseptic Manufacturing.
  • Develop Aseptic Processing Training curriculum for site and oversee implementation of Instructor-led training, Lead Aseptic Core Team, Propose and Implement Continuous Improvement Projects, Participate in Aseptic Strategic Teams, Conduct Aseptic Behavioral Audits of Production, nominated SME for Aseptic Operator Certification; Created bi-weekly Aseptic Awareness bulletins.
  • Conduct Weekly Safety Audits, Production WIP review, Log book and Batch Record review, Write/revise/approve and harmonize Standard Operating Procedures, Assist wif developing task-specific trainings identified in CAPAs, Participate in Media Fills and Smoke Visualization studies, Collaborate wif ASPEX to standardize processes, Serve as a liaison for vendors who provide sterile suppliesAseptic Trainer, Operational Compliance (Sept. 2011- Jan. 2016)

Confidential, Waco, TX


  • Responsible for all aspects of the Aseptic Certification Program including, administering written and practical exams, performing audits, managing annual re-certifications and de-certifications.
  • Performs assessments, investigations, and identify gaps for Aseptic processes such as sterilization and cleaning, media fills, and aseptic fill interventions; Propose and implement process improvements (Continuous improvement projects).
  • Performs Hands-on training for gowning for aseptic/controlled areas, aseptic manipulations, safety and New Hire Orientation. Created Train-the Trainer for Gowning in order to certify back-trainers for gowning, Teaches Microbiology to new hires.
  • Led initiative to assemble an “Aseptic Team” in Production, Review and/or revise all site documents dat pertain to cleaning, gowning, microbiology, and aseptic practices; Performs routine auditing of Manufacturing areas and implemented Behavioral Audits for the Waco Site.
  • Responsible for internal and external audits as assigned by QA Dept. Participated in site Regulatory Inspections (FDA, KFDA, LNE, HPRA, MHRA, Japan, Senju, Russia, Canada, Kazakhstan, Turkey, Zimbabwe) - Subject Matter Expert for Aseptic Training/Microbiology.
  • Championed Aseptic Processing Training and Intervention Training for Mechanics, Department representative for Safety. Implemented the Aseptic Training/Gowning Program for Confidential counterparts in Korea.
  • Presented GMP Auditing Sterile Production (2014) and Prevention and Control of Microbial Contamination (2015) and Managing Laboratory OOS (2015) at national conferences as SME. Received 2 company Awards of Excellence in 2015.

Microbiology Lab Supervisor

Confidential, San Antonio, TX


  • Manage all aspects of Microbiology testing and processing of blood bank samples. Restructured laboratory and purchase new equipment and updated software.
  • Oversee implementation of new equipment (LAF, Sampling Devices, Gram-Stanier, VITEK, Camera for Microscope, Networking Systems), testing materials, reagents, and troubleshoot existing equipment.
  • Prepare validation protocols; Write and revise Standard Operating Procedures; Create Logbooks/Controlled Forms, Implement Environmental Monitoring for controlled areas; Generate and respond to QIRs (Quality Improvement Reports); Perform trend analysis; Participate in core value teams and generate continuous improvement projects.
  • Re-vamped the lab training programs to include formal GMP, LabSafety, and Microbiology 101 training; Process Improvements/Compliance (Revised specifications to conform to current standards, extended incubation time, changed acceptance criteria for microbial identifications) Prepare employee work schedules; Set goals and objectives and conduct evaluations for hourly personnel.
  • Coach employees to develop Time Management skills, Identify opportunities for improved efficiency, Ensure employees meet competencies. Order supplies; work wif vendors to set up-standing orders for media/supplies Prepare budget for Lab.

QA Microbiology Sr. Professional

Confidential, Waco, TX


  • Supervisory role in Support of Aseptic Processing at the Waco manufacturing facility; Provide oversight of GMP/GLP processes including media fill program and aseptic gown qualification program for Unit Dose, Sterile Fill, Ointment, Gel, and Steroid products.
  • Prepare validation protocols and final reports for media fills; Write media fill investigations; Schedule media fill dates in accordance wif site Master Validation Plan; Provide training to Production personnel.
  • Monitor filling process; Oversee Day-7 and Day-14 media inspections; Write SOPs, Contribute to SOP revisions; Work closely wif Planners, Validation, QA, Microbiology Professionals, Fill Supervisors, Engineers, and Batch Review Dept. to meet Customer Service timelines; Oversee Microbiology lab water testing of site, microbial limits testing, growth promotion, disinfectant studies, BI testing, bioburden testing.
  • Write investigations/ QMS deviations/CAPA, release batches in SAP, Coordinate implementation of endotoxin testing in laboratory and clean steam samplers for water testing, Prepare test scripts and execute IQ/OQ/PQ for endotoxin equipment, train new hires; Manage customer complaints sent from Corporate; Prepare and present trend reports; Order media supplies; Supervise and mentor hourly personnel.
  • Participant in investigative teams; Perform laboratory audits, Participate in SafeStart Program, Support internal and external audits. LIMS new generation implementation team, champion for consultants/identification of lab inefficiencies, opportunities project team.

Associate Research Scientist

Confidential, New Brunswick, NJ


  • Write Microbiological Qualification Protocols for R&D and BMS Worldwide Technology Transfers, Write Laboratory qualification reports, Review SOPs against current compendia, Manage Long-term Stability Studies, Research new equipment and host vendor presentations.
  • Validate new equipment (IQ/OQ/PQ), Write IOPs for new equipment, Conduct dept. meetings and training, Conduct routine Micro and Chem Laboratory safety audits and perform monthly checks of safety equipment, contact facilities for equipment repair and follow-up, Supervise all water testing for 2 sites (BET, microbial growth, TOC, Conductivity, pH) and report results/OOS, Validate new water system.
  • Validate R2A Media, Develop an environmental monitoring program, Perform Laboratory Investigations, Perform daily review of notebooks and autoclave charts, Perform weekly review of Incubator and Refrigerator temperature charts, Compile laboratory inventory lists and order media supplies.
  • Provide input on the design of a future Micro. Lab, provide training to Analysts, Samplers, and Facilities and Manufacturing personnel, Approve employee timecards and OT.

Assistant Scientist

Confidential, Raritan, NJ


  • Environmental monitoring of manufacturing, purification and filling areas, sampling and testing of water, BET, microbial limits testing, bioburden testing, water activity, preservative efficacy testing, BI certification, growth promotion, participate in media fills, identification of microorganisms, monitoring laboratory equipment, freezing and shipping samples, initiating investigations, trending data, and performing lab safety audits.

Micro Lab Technician

Confidential, Orangeburg, NY


  • Team leader in charge of environmental monitoring, microbial limits testing, sampling and testing water, sterility and bioburden testing, calibration of incubators using RL-100 temperature recorders, growth promotion, media preparation, maintenance of stock cultures, writing investigations, and autoclaving.Quality Control Technician (1997 - 1998)

Confidential, Newburgh, NY


  • Washer validation, water testing, environmental monitoring of cleanroom and personnel, performing particle counts and resistivity tests on garments, penicillin testing, monitoring HEPA filter velocities and cleanroom temperatures, inspecting incoming components, bioburden, writing and revising SOPs, trending, autoclaving, and sanitization of cleanroom.

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