US-GA, Quality Control Analyst Microbiology SR0024855-MZ
Takeda 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 biological, chemical and physical analyses on pharmaceutical products and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs. Conduct critical biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.Work under minimum supervision. Serve as Mentor to Quality Laboratory Associate (QLA) I positions. Provide training and work direction for QLA I positions as required. Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems. Use sophisticated laboratory instrumentation and computer systems to collect and record data. 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 and specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents. Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality. Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs. Perform equipment maintenance and calibrations as required. Proficient in wet and instrumental methods of analyses. Advanced laboratory skills, basic knowledge of statistical method. Strong technical problem solving skills. Ability to handle multiple tasks concurrently, and in a timely fashion. Computer literate. Must be able to communicate effectively with supervisors and peers. Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion. 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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Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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