At MilliporeSigma, as the Quality Specialist 1, you will perform a variety of tasks within the Quality Assurance department, including conducting audits and the reviewing / approving of various types of regulated documentation : Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers and other quality recordsReview and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysisReview and approve deviation records and validation files for systems and assaysConduct laboratory inspectionsShift : Monday-Friday 10 : 00am to 6 : 30pm Who You Are : Minimum Qualifications : Bachelor’s Degree in a scientific discipline (e.
g., Biology, Biotechnology, Chemistry, etc.), OR a Bachelor’s Degree in a technical discipline (e.g., Computer Science, Information Technology, etc.
6+ months work experience in GMP / GLP environmentPreferred Qualifications : Strong work ethic and quality of workExperience meeting deadlinesWorks with cross-functional teams and builds networks within QA and Operations departmentsOpen-minded and flexibleBasic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.
Familiarity with International regulations (EMA, MHRA)Strong verbal and written communication skills
Quality Assurance Specialist
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The Quality Assurance (QA) Specialist will work directly with and independently from software engineers using manual and automated testing procedures to ensure system issues are identified and resolved before and after deployment. This role involves creating and maintaining test cases, documenting f...
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The Quality Assurance (QA) Specialist will work directly with and independently from software engineers using manual and automated testing procedures to ensure system issues are identified and resolved before and after deployment. This role involves creating and maintaining test cases, documenting f...
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At MilliporeSigma, as the Quality Assurance Specialist 2, you will perform a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation. Quality Assurance in a science field or a GxP environment. Review and a...