Drug Product Inventory Specialist
Resume:
Peter Le
*****.*.****@*****.***
PROFESSIONAL SUMMARY
Highly motivated worker and goal oriented
Solid communication, interpersonal, time management, and leadership skills
Go-getter attitude with an ability to easily grasp new ideas, concepts, methods, and procedures
WORK HISTORY
Eyenovia
Lead Operator April 2022 – Present
Supervised and performed aseptic filling, equipment preparation, packaging, and drug product visual inspection
Lead the efforts for the production team to comply with the company’s policies and procedures
Cleaned, Set-up, and broke down the production lines for aseptic filling and operation
Trained new hires on aseptic techniques, filling process, and assembly of cartridges
Performed and supported multiple operations with aseptic filling and our production assembly line
Created and revised multiple SOPs, Forms, Work Instructions, and Manufacturing Instructions
Initiated, identified, and closed out CAPA reports to help improve operations and procedures
Facilitated workgroups to identify true root cause using Fishbone Diagrams and 5 Why’s.
Proficient with Cetec, the company’s ERP system to manage company’s inventory and work orders
Performed cycle counts, receiving shipments, and checked inventory daily as the interim Inventory Specialist
Revance Therapeutics
Drug Product Fill/Finish Senior Manufacturing Technician June 2018 – April 2022
Application of GMP, cGMP, GDP, and safety guidelines in conformity of FDA and CDC regulations
Worked in an aseptic area with DaxibotulinumtoxinA
Compounded solutions for DaxibotulinumtoxinA and buffer
Created, redlined, and revised SOPs, forms, work instructions, and specifications
Initiating, Investigating, and Closing of deviations reports
Helped with implementation and qualification multiple equipment such as the filler/isolator, vial washer, and glove tester.
Equipment Specialist lead on multiple manufacturer equipment
Created training programs for new hires as the team trainer
Helped improved the production process as the CAPA and Change Order Record owner
Worked closely with supporting groups such as QA, QC, Document Control, and Facilities to ensure that the production schedule are met daily
Tesla Motors
Quality Control/Quality Inspector October 2017 – June 2018
Served as Back-Up Lead and delegated tasks to other employees
Inspected panels for any anomalies or defects on the manufacturing floor prior to leaving for the assembly line and paint
Served as Safety Coordinator and scheduled meetings to help improve the safety of our environment on the manufacturing floor and for the people around
Created a training program for new hires as well as trained new hires on daily tasks, QC expectations, and operations
Worked with multiple supporting groups such as the production team Supervisors and Managers, Paint, Stamping, Instrumentation, Mechanics, and Engineers to ensure that the daily productions goals were met
Extensive knowledge of the end-to-end process in case of any anomalies or defects were found, I would be able to locate and remove the defected parts on the manufacturing floor and then escalate to the proper channels to keep production on schedule
Genentech
Senior Pharmaceutical Technician – Fill/Finish September 2013 – October 2017
Delegated tasks to technicians to ensure production schedule is met daily and escalated any issues to the appropriate channels to move forward with operations as back-up lead
Provided up to date training such as clean room gowning and operating machinery as shift trainer
Performed drug product aseptic operations per cGMPs, SOPs, and industry standards
Performed aseptic techniques in a grade A 100 clean room environment during commercial filling operations
Extensive knowledge of end-to-end process of filling and bulk operations
Worked closely with supporting groups such as quality assurance, quality control, PEME, MSAT. bulk group, and other shift supervisors to ensure the production schedule are met daily
Provided room owners with tools and information to complete daily 5S
Reviewed documentation of daily operations to ensure technicians were properly documenting their task
Quest Software (Acquired by Dell in 2012)
Sales Associate January 2012 – August 2013
Handle inquiries at all business and technical levels of each client's organization from their CEO down to their Network Administrator
Established and maintained client relationships by providing appropriate IT solutions based on the client’s specific needs and interests
Researched prospective customer’s IT business needs to promote and sale ideal product packages
Effectively sale IT strategies through all aspects of the sales cycle, including extensive cold calls, on-site presentations, demonstrations, price negotiations and the closing processes
Met monthly and quarterly sales goals set by my direct manager
Wells Fargo Bank, N.A.
Personal Banker/Assistant Store Manager May 2008 – December 2011
Established and maintained client’s loyalty by building trust-based relationships and providing exemplary customer service and financial advice across all products
Mentored, trained, motivated and empowered team members and new sale representatives to focus on excellent customer service and achieve sale goals
Proactively took on new projects to expand my expertise in sales and operations
Selected as a trainer from San Francisco district to fly to Atlanta, GA to train Wachovia employees of Wells Fargo Bank’s procedures and standards during the Wachovia acquisition
Recognized with the annual customer excellence award in 2009 and the quarterly highest district sales achievement award in 2010
EDUCATION High School Diploma
Grace M. Davis High School Graduated in 2003
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