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BioLife: Lead Quality Assurance Specialist Ii

Zoek Pin Social Circle, Georgia


Permanent (Full time)

Posted 40 days ago

Job Description Conduct biological, chemical and physical analyses on raw materials, initial, in-process, Stability and final products Write and execute validations and/or protocols for manufacturing processes and laboratory instruments and methods May serve as a mentor to other Quality Laboratory positions. Lead day to day activities of the laboratory operation including (but not limited to): providing training and work direction for laboratory technicians as required. Scheduling, identifying priorities and assigning tasks as needed and ensuring timely completion of tasks Manage workflow and laboratory release functions in specified laboratory areas and on off shifts. 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 laboratory assays requiring precise analytical skills and understanding of scientific principles. Work on special project/protocol testing that involves new methods and instrumentation. 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, improve quality and provide new product support. Perform laboratory and manufacturing audits as required. Audit and update, as required, SOPs. Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems. Work with minimal Supervision. Bachelor's degree in chemistry, biological science, or biological science with a minimum of 5 years of related experience or a Master's Degree in Chemistry or biological science with 1-4 years' experience Proficient in wet and instrumental methods of analyses. Advanced laboratory skills and basic knowledge of statistical method. Strong technical problem solving skills Ability to handle multiple tasks concurrently, and in a timely fashion. Must communicate effectively (verbal and written) with supervisors and peers. Must demonstrate effectiveness in ability to train others Knowledge of most laboratory equipment including but not limited to autoclaves, incubators, analytical equipment Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Knowledge of basic chemical and biological safety procedures. * Good computer skills, knowledge of Microsoft Word, Excel and Powerpoint. Notice to Employment / Recruitment Agents: Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda's Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Equal Employment Opportunity 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. EEO is the Law EEO is the Law Supplement Pay Transparency Policy Reasonable Accommodations Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call######### and let us know the nature of your request and your contact

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