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 : Shift : Monday Friday 10 : 00am 6 : 30pmReview 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 inspections 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 environment Preferred 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
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