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Senior Quality Control Analyst Biochemistry

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Conduct critical biological, chemical and physical analyses of in-process and final products to support manufacturing facility production schedules. Perform documentation and review of test data following good documentation practices. Enter final data in LIMS and other computerized systems.

Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner.

Maintain data integrity and ensure compliance with company SOPs, product specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents.

Participate in team functions to address production, increase efficiency, solve problems, generate cost savings and improve quality. Perform laboratory and manufacturing audits, as required. Audit and update processes and facility SOPs, as required.

Perform equipment maintenance and calibrations. Work under minimum supervision. Conduct other duties as assigned.

Requirements:

Proficiency in both manual methods and instrumentation analyses. Experience performing and analyzing serology and immunology assays.

Basic knowledge of statistical methods and strong technical problem solving skills.

Ability to conduct multiple tasks concurrently to meet critical timelines.

Effective communication skills, ability to train others.

Proficient use of TrackWise, SoftMax Pro, and MiniTab software a plus.

Qualifications:

Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.



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