QC Operations Specialist II

Your next role as a Miracle Maker

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Control team as a QC Operations Specialist I. As a QC Operations Specialist II you will beresponsible for providingtesting andtechnical oversightin Method Development Qualification Validation/Verification of QC test methods related toincoming raw materials in-process materials and final manufactured products.This successful candidate will thrive in aflexiblefast-paced environment anddemonstratedexcellent attention to detail.

How you will make an impact:

• Routinelyoperateanalytical (U)HPLC mass spectrometerGas ChromatographypH/conductivity meterTOC Analyzer Viable and Non-Viable Air samplerqPCR dot blot UV-vis spectrometer FTIR Fragment Analyzer and restriction digests.
• Generates and executesmethodqualification/validation protocols.
• Troubleshoots routine equipment issues within the laboratory
• Is a technical subject matter expert on a variety of analytical instrumentation( mass spectrometer pH/conductivity meter qPCR dot blot UV-vis spectrometer FTIR Fragment Analyzer TOCEndoToxinAnalyzer)
• Ensures that all product specifications are met and follows proper procedures for out-of-specification (OOS) results and reporting of non-conforming materials.
• Conducts investigations and provides first tier analysis of complaints and non-conforming products.
• Primary peer reviewer of testing data and write-ups of other technicians for accuracy and completeness.
• Serves as lead QC contact for communication to manufacturing and order fulfillmentregardingtesting schedule and product readiness.
• Trains anddevelopsnew team members on test methods.
• Serves as delegate for QC Management.
• Maintains meticulous documentation of all Quality Control records.
• Creation of QC standard operating procedures andoptimizingnew/existing analytical test methods.
• Assistswith instrument calibrations and preventative maintenance.
• Maintains lab housekeeping organization and inventory supply.
• Performs other functions and duties as.

The skills and experience that you will bring:

• B.S. or advanced degree in chemistry or biology or a related scienceor a minimum of6-7years of experience working in a laboratory manufacturing or quality role within the life science industry.
• Hands on experience withmultipleof the following instrumentation: HPLC Mass SpecGCqPCR UV-Visspectrophotometer Fragment Analyzer TOC AnalyzerEndotoxin Analyzer Viable and Non-Viable Air samplers.
• Hands onexperience in executing Method Development/Qualification/Validation/Verification activities.
• Familiar with USP<1225>Validation of Compendial Proceduresand/or ICH Q2(R2) Validation of Analytical Procedures.
• Familiar with Chromatography Data Systems ().
• Computer skills (Database software Microsoft Office Suite)
• Strong knowledge of and experience using GLP orcGMPprinciples.
• Working knowledge of standard chemical safety/hygiene requirements and overall safe workplace practices especially in a laboratory setting.
• Ability to work independently with little to no supervision.
• Strong verbal and written communication skills.
• Strong interpersonal skills.
• Strong problem solving observation skills and attention to detail.
• Self-motivated and able to organize and prioritize multiple tasks.

The anticipated salary range for this position is $76246 - $85988. In addition highly competitive long-term incentives in the form of company equity bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidates skills experience and other qualifications as well as the location of the role.

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