Looking to transition into new field after developing strong foundation in high-volume manufacturing environment. Skilled in analytical testing, aseptic technique and quality assurance, ensuring efficient and accurate production. Seeking to leverage these transferable skills in dynamic and challenging new role.
Overview
3
3
years of professional experience
Work History
Manufacturing Associate I
Amgen
Thousand Oaks, CA
09.2024 - Current
Executed various analytical methods utilizing strong aseptic technique and current good manufacturing practices
Executed data entry, approved test results, and managed sample handling processes within LIMS
Examined batch records to support timely rush sample testing, buffer release, and drug substance release products
Reconciled and archived various forms to ensure compliance with GDP and ALCOA+ principles using Infolinx
Facilitated on-the-job training as an instructor, certifying staff on training qualifications (TRNQs) within the Learning Management System (LMS) for various analytical testing methods.
Revised SOPs and procedures to support audit readiness following endotoxin testing major deviation.
Cross-functionally trained individuals among different teams and buildings in reconciliation and analytical methods
CW-MCS Manufacturing Associate
Actalent Scientific, LLC at Amgen
Thousand Oaks
02.2024 - 09.2024
Executed analytical testing methods, including endotoxin, protein concentration, total organic carbon, offline conductivity, osmolality, and gold particle analysis.
Exhibited proficiency in pipetting and aseptic technique for in-process testing, rush sample testing, and drug substance release
Applied gowning knowledge to ensure compliance with grades 7,8 and 9 standards.
Utilized manufacturing execution system (MES) and laboratory information systems (LIMS) for data entry, receiving samples, and movement of samples.
Supported sample management processes including handling and disposal following 5S methodology, good documentation practices, and cGMP standards.
Demonstrated adaptability in response to evolving manufacturing conditions and product specifications.
Laboratory Associate
Hygiena, LLC
Camarillo
04.2023 - 02.2024
Executed laboratory maintenance protocols to uphold cleanliness and ensure optimal functionality of equipment.
Produced diverse growth media and bioluminescence reagent solutions utilizing aseptic techniques in an ISO 9001-certified laboratory environment.
Executed in-process testing on reagent sample collections to ensure accurate communication of product specifications to R&D and cross-functional teams.
Conducted environmental testing using vacuum filtration methods to identify and isolate microorganisms, including E. coli, in growth media solutions.
Oversaw operation of spectrophotometer, pH meter, pipette, and orbital shaker for reagent solution testing.
Revised lab procedures and SOPs to enhance reagent production efficiency
Laboratory Inventory Control Associate
HRL Laboratories, LLC
Malibu
02.2023 - 03.2023
Designed comprehensive Excel spreadsheets to enhance organization and labeling of diverse property and equipment.
Leveraged online inventory control system to streamline property location processes.
Managed logistics for relocating property and instruments to appropriate waste departments and off-site locations, optimizing resource utilization.
Conducted thorough investigations of inventory discrepancies to support accurate inventory management practices.
Manufacturing Associate I at Minaris Advanced Therapies (formerly WuXi AppTec)Manufacturing Associate I at Minaris Advanced Therapies (formerly WuXi AppTec)