Quality Control Analyst II

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Shire Human Genetic Therapies, Inc. for the following job opportunity:

JOB LOCATION: Lexington, MA

POSITION: Quality Control Analyst II

POSITION DESCRIPTION: Shire Human Genetic Therapies, Inc. is seeking a Quality Control Analyst II with the following duties: test biochemistry analytical methods for release and stability samples using qPCR (Quantitative Polymerase chain reaction), Kinetic Activity, Osmolality, Specific activity, Enzyme Activity, A280-320 protein concentration, pH, visual inspection and Reconstitution methodology. Provide subject matter expertise to junior level analyst in the lab. Proficiently use pH Meter, UV Spectrophotometer and solo VPE (Visual path extension), M5 and 384 Plate readers, 7500 fast Real-time PCR (Polymerase chain reaction) system and Osmometer. Provide support on maintenance of lab instruments in support of GMP (Good manufacturing Practices) testing. Apply proficiency in GMP laboratory systems including LabX, SoftMax pro, Spectramax and AccuSEQ. Review and report assay data efficiently using LIMS (Laboratory information management system) software. Perform data analysis and verification using LIMS, Minitab, JMP (John's Macintosh Project) software for method development. Initiate lab deviations or OOS/OOT (out of specification/out of trend) observed during analytical testing and perform investigations and root cause analysis using Trackwise software. Support method validation. Integrate 5S Activities for GMP laboratories and clean room environments. Collaborate on periodic reviews, SOP (Standard operating procedures) Generation/revision, and generate CAR (control-assignment reports) using CAP (control-assignment protocol) in Veeva.

REQUIREMENTS:  Bachelor’s degree in Biotechnology or related field, plus 5 years of related experience. Prior experience must include: Periodic Reviews, protocol revisions, Generating CAP and CAR reports in Veeva, initiation of Lab deviations or OOS/OOT observed during analytical testing and perform investigations and root cause analysis using Track wise software; analyze Data Maintenance of pH Meter, UV Spectrophotometer and solo VPE, M5 and 384 Plate readers; analyze and verify data with LIMS, Minitab, and JMP software for method development, analyze and test QC analytical methods on DS and DP samples using Compendial methods, qPCR, Specific activity, Enzyme activity, Kinetic activity techniques; design and conduct biological, chemical, and physical analyses of raw materials, in-process, and final product samples to support manufacturing, validation, process development, and stability studies in a GMP environment, research and utilize sophisticated laboratory instrumentation and computer systems, such as LIMS, to collect and record data; analyze and apply PCR techniques and Gel Electrophoresis for molecular analysis.

Full time. $102,000 to $151,000 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0161095. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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