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Aseptic Certification Trainer (interim) Resume Example

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ASEPTIC CERTIFICATION TRAINER (INTERIM)
Summary

Over 16 years in a pharmaceutical/FDA industry where I held various positions in aseptic prep, as a manufacturing lead in global packaging and aseptic filling and as an aseptic certification trainer.

Highlights
  • Excellent communication, customer service, conflict resolution and leadership skills.
  • Ability to work effectively with different department supervisors and personnel.
  • Strong knowledge of the pharmaceutical manufacturing process, manufacturing performances and financial attributes such as material variances, yields and efficiencies and LEAN manufacturing.
  • Self-motivated.
  • Results driven.
  • Ability to work independently and as a team.
  • Execute with urgency.
  • Strong knowledge of the inventory control system PRISM/ERPLx.
  • Detailed Oriented.
  • Effective written and verbal communication skills.
Experience
Aseptic Certification Trainer (interim)
July 2014 to CurrentCompany Name － City, State
  • Administer aseptic behavior certification program for associates working in the manufacturing aseptic environment.
  • Audit associates entering aseptic environment on a daily basis.
  • Ensure compliance with gowning and aseptic techniques.
  • Monitor Process Simulation Media Fills and commercial runs to identify additional training needs and develop training materials to address those opportunities.
  • Maintain consistent coordination with Manufacturing & QA Management and generation of reports.
  • Develop and deliver GMP course modules related to proper aseptic behavior and maintaining an aseptic environment.
  • Coach and mentor operators on the importance of maintaining low bio burden during line clearing / cleaning, runs, routine and non-routing interventions.
  • Evaluate and develop action plans for employees showing alert limits in the garment sampling.
  • Assess equipment and work environment to ensure it is suitable to enable good aseptic behavior and makes recommendations to management on changes needed.
  • Write non-conformance investigations
  • Evaluate from the aseptic perspective any equipment modification, process changes, new equipment and new tools to be introduced inside the aseptic area.
  • Serve as escort during internal audits associated with the Compliance department.
  • Responsible to conduct readiness activities for medias, shut downs and other non-commercial activities.
  • Represent Management in Meetings such as FMEAs, Kaizen events, etc.).
  • Own Business Unit tasks and CAPAs to improve quality and / or efficiencies.
  • Serve as back up operational Manufacturing Line Lead.
  • Support OpEx initiatives.

Manufacturing Lead II
April 2006 to July 2014Company Name － City, State
  • Coordinate the production activities for filling and packaging lines.
  • Communicate the production plan with the manufacturing manager.
  • Maintain aseptic gown certification, QC certification, PRISM/ERPLx certification, visual inspection certification, and line clearance and LOTO certifications.
  • Evaluate quality issues with the QC Team Leader.
  • Responsible for GMP, ISO and environmental health and safety procedure awareness and compliance within the respective area.
  • Participate in improvements for material variance, quality indicators, and line efficiencies.
  • Provide feedback to the reporting manager regarding associate performance and behaviors.
  • Assign tasks for manufacturing operators and support associates.
  • Coordinate and perform the set-up and changeover of manufacturing equipment.
  • Verify component readiness.
  • Perform audits on equipment for line cleanliness and compliance.
  • Review and audit batch records to fulfill RFT and OTP expectancies.
  • Perform initial and ongoing training and development of associates.
  • Support and encourage LEAN manufacturing.
Aseptic Prep Operator III
November 1998 to April 2006Company Name － City, State
  • Strong knowledge of operating and cleaning sterilizing equipment such as dry heat ovens, CIP/SIP skids, and autoclaves to maintain production schedules.
  • Cleaned and prepared filling and compounding parts for sterilization.
  • Cleaned and sanitized aseptic and non- sterile manufacturing/laboratory areas, Classified as A, B, C, D, areas with approved disinfectants.
  • Prepared disinfectants and aseptically filter sanitizing agents into the aseptic area.
  • Performed aseptic connections to assure proper sterilization of transfer lines inside the aseptic environment.
  • Disassembled and assembled precision filling and compounding equipment for cleaning and sterilization.
  • Performed cleaning of the process vessels including rinse water UV / conductivity testing.
  • Performed visual integrity inspections of sterilized equipment as well as pressure and vacuum testing on equipment parts.
  • Performed non-sterile and aseptic prep cleaning and sanitizing activities per specific batch record and SOP requirements.
  • Park Ops Host/Ride OJT.
Ride Operator/Trainer
December 1996 to December 1998Company Name － City, State
  • Greet guests and provide World Class Service.
  • Answer guest questions and advise them on show times and park attractions.
  • Train new employees on operating ride equipment.
  • Perform miscellaneous duties as assigned by the area supervisor.
  • Maintain park cleanliness, including sweeping, picking up trash, changing trash can liners, picking up trays, mopping and changing restroom paper dispensers.
  • Maintain guest safety at ride locations, ensuring height restrictions, platform duties and operate the control panel.
Education
Bachelor of Science : Business Management, 2016St Leo University － City, State, USA

Business Management

Associates : Business Administration, 2010University of Phoenix － City, StateBusiness Administration
Certifications

Aseptic Gowning certified - ISO 9001 and 13485 Certified - Environmental Monitor certified - Visual Inspection certified - QC certified - Line Clearance certified - PRISIM/ERPLx certified - LOTO certified

Skills

Excellent communication, interpersonal, conflict resolution and leadership skills. Strong knowledge of the pharmaceutical manufacturing process. Results driven. Execute with urgency.

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Resume Overview

School Attended

  • St Leo University
  • University of Phoenix

Job Titles Held:

  • Aseptic Certification Trainer (interim)
  • Manufacturing Lead II
  • Aseptic Prep Operator III
  • Ride Operator/Trainer

Degrees

  • Bachelor of Science : Business Management , 2016
    Associates : Business Administration , 2010

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