Sr Site Specialist

at  Thermo Fisher Scientific

JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $50 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies, or growing in their laboratories, we are here to support them.

• 
  
  
  
• Ensure proper training (EHSS, SOPs, TRNQs) is completed in a timely manner

• Triage safety or compliance incidents and participate in investigation & CAPA execution
• Adjust schedules as appropriate to manage peak workloads
• Track and report operational metrics, savings initiative
• Participate in internal and client meetings related to QC
• Provide in-lab operational support on an as needed basis including:
• Operator level gowning for entrance and work performed in manufacturing suites
• Operation of Waters and Agilent HPLC analysis systems using SEC, IEC, RPC, and Affinity chromatography methods
• HPLC Analysis for Purity, Identify, and Concentration (PIC) for STAT and non-STAT samples
• Interpret HPLC result data for molecule PIC based Method acceptance criteria
• Independent data verification of HPLC analysis product for PIC
• Communication with manufacturing management analysis results for forward processing of commercial product
• Ensures that, equipment, materials, processes, and procedures align with cGMP practices and other applicable regulations
• Alerts Customer management of quality, compliance, supply and safety risk
• Maintaining metric data for work performed
• Maintain Quality Control reagents within customer validated Consumable Inventory Management System (CIMS), including adding reagents, uploading C of A, determination of chemical equivalents, crafting sub-inventories, and discarding of items
• Perform primary trainer responsibility for customer validated Methods and procedures
• Participate in individual or group projects that can include, cost savings analysis, learning groups, writing job training methods,