Arsalan Aslam

About Arsalan Aslam

Experienced in analytical chemistry and materials control in support of sampling, inspection, and testing of raw materials in support of manufacturing. As well as leading teams in development, validation, and routine testing of product through the performance of analytical assays while interacting with Production, Quality Assurance, Validation and Facilities, and external clients and resources, as necessary to support manufacturing.• Experienced in laboratory techniques such as HPLC/UPLC, AKTA FPLC, TOC, UV-Vis, Atomic Absorption (Flame and Furnace), ICP-OES, ICP-MS, FTIR, PSD (Malvern Mastersizer and OGP SmartScope Flash 200 and 302, Sepha Multi-Q (CCIT)Analyzer, and Dissolution, to work efficiently either independently or under guidance in a team environment.• Experienced in the execution of method transfers and method qualifications, laboratory improvement projects, authoring investigational protocols and reports, change control requests, troubleshooting of analytical methods and instruments in collaboration with teams as appropriate.• Strong learning ability, project and people management skills, and implementation of techniques to effectively move projects as required.• Excellent problem solving, planning and coordinating testing schedules, organizing, written/verbal communication and computer skills, including use of IDBS ELN, LIMS, Empower, TotalChrom, TrackWise, Veeva Vault, and MasterControl. • Strong interpersonal and cross-functional skills to work effectively with people at all levels of the organization.

Experience

1. Quality Assurance Validation and Technical Support Specialist

   Amgen

   Oct 2023 — Present · NC, US

   Performs quality review and approval of documents to support facility commissioning and qualification, Validation Protocols, Validation Reports, according to project timelines.• Provides quality guidance and support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.• Provides quality oversight for quality records including deviations/CAPAs, change controls and work orders ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate• Site Data Integrity Co-lead, providing training for new staff along with refresher training for Data Integrity Assessments, ensuring Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls are followed.

Education

• LSU Shreveport

  Master of Business Administration - MBA

• SUNY New Paltz

  B.S, Biology (Cell/Molecular)

  2006 — 2010