Sr Site Specialist -QC Lab Support - West Greenwich, RI

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 complex analytical challenges, improving patient diagnostics and therapies or growing in their laboratories, we are here to support them.
Location: West Greenwich, RI
Hours: first 6 months, M-F, 7:30 - 4:00, then after that it would be flex shift

WHAT WILL YOU DO?

• The STAT titer portion of this role directly supports commercial manufacturing.
• During coverage for STAT Titer, this position works variable shifts including second shift, third shifts, nights, weekends, and holidays in order to accommodate the manufacturing schedule.

JOB-SPECIFIC DUTIES MAY INCLUDE:

• Use of validated electronic laboratory sample database to create samples, and maintain sample inventory within a LIMS system
• Operator level gowning for entrance and work performed in manufacturing suites
• Sample preparation of drug product and drug substance
• 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
• Perform first level troubleshooting on HPLC systems, including change out of external and internal components
• 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
• Perform Biological Indicator testing on manufacturing samples for microbial growth
• Align with safety guidelines and regulatory requirements
• Ensures that, equipment, materials, processes, and procedures align with cGMP practices and other applicable regulations
• Alerts Customer management of quality, compliance, supply and safety risks
• Completes required assigned training to permit execution of required tasks
• Utilization of Good Documentation Practices in all record keeping
• Maintaining metric data for work performed
• Perform equipment verifications and calibrations following customer and manufacturer’s protocols
• 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
• Strict adherence to customer Standard Operating Procedures and Method protocols
• Perform primary trainer responsibility for customer validated Methods and procedures
• Promote a safe work environment through various safety initiatives within functional area
• Participate in individual or group projects that can include, cost savings analysis, learning groups, writing job training methods, and leading team meetings