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.
Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
Review 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 analysis.
Review and approve validation files for assays. Review and approve minor, major and critical impact deviations / OOS records.
Conduct trend analysis for deviations and review / approve applicable CAPA records. Conduct laboratory inspections to include commissioning and / or internal audits.
Provide support for client regulatory submissions, client audits and supplier audits. Review and approve client and supplier quality agreements.
Shift : 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.
2+ years' experience in Quality Assurance in a science field or a GxP environment. Preferred Qualifications : Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.
Familiarity with International regulations (EMA, MHRA).Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
Strong communication and interpersonal skills. Acts ethically and ensures quality of own work and that of others. Open-minded, flexibility and works with agility.
Ensures deadlines are met by taking initiative. Works with cross-functional teams and builds networks within QA and Operations departments.
Collaborates with various teams to identify and implement improvements.
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