Quality Assurance Specialist 2
Millipore Corporation

At MilliporeSigma, as the Quality Specialist 2 - Assay Validation, 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: Assay validation data review and analysisConducts audits and the reviewing/approving of various types of regulated documentationReviews and approves assay validation and assay transfer protocols in accordance with SOPs and regulatory expectations (e.g., GMP, ICH)Performs data review and analysis of assay validation dataReviews and approves standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality recordsReviews and approves study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysisReviews and approves validation files for assays and approve minor, major and critical impact deviations / OOS recordsConducts trend analysis for deviations and review / approve applicable CAPA records and conducts laboratory inspections to include commissioning and/or internal auditsProvides support for client regulatory submissions, client audits and supplier audits. Review and approve client and supplier quality agreementsMonday-Friday 10:00am - 6:30pm

Who You Are:

Minimum Qualifications:

Bachelor's Degree in any discipline 2+ years in a quality role

Preferred 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 or related field within a GxP environmentStrong work ethic and quality of workExperience meeting deadlinesWorks with cross-functional teams and builds networks within QA and Operations departmentsOpen-minded and flexibleProficient knowledge and application of FDA (21 CFR Parts 11, 58, 210, 211 etc.) and EU regulations (cGMP, GLP, Data Integrity)Familiarity with International regulations (EMA, MHRA)Strong communication and interpersonal skills