6 associate qa engineer jobs at 6 companies in Gardner, MA
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Associate Director, GMP QA Operations
Waltham, Massachusetts, United States
$160k-$195k/yrOnsiteFull Time
Dyne TherapeuticsNASDAQ: DYN: Developing therapeutics for genetically driven neuromuscular diseases.
8+ YOEBachelor's in engineering/science (Master's preferred), 8+ years in cGMP environment and 5+ years in QA, experience overseeing CMOs/CDMOs, knowledge of FDA/EMA regulations, GxP QA systems, strong communication and decision-making skills.
1+ YOEBS in engineering, proficiency with Windows and Microsoft Office, QA experience in AS9100/AS9102 environments, ability to obtain DOD security clearance, strong communication and problem-solving skills.
Windows, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Electronic Medical Records (EMR)
IBMNew York Stock Exchange: IBM: Global technology providing enterprise software, cloud, and consulting.
Associate's degree or college diploma; experience with agile testing, testing standards, exploratory testing, test automation frameworks, and collaborative story development. Work authorization without current or future visa sponsorship required.
Agile, unit tests, integration tests, functional tests
Genetix Biotherapeutics: Developing and commercializing curative gene therapies for rare diseases.
4+ YOEBachelor's degree in life sciences, engineering, or related field; 4-6 years of QA experience in GMP-regulated biopharmaceutical or cell/gene therapy manufacturing; CMO oversight experience and cGMP knowledge.
12+ YOEBachelor's in Engineering/IT/CS, minimum 12 years in pharmaceutical quality/QA/CSV/IT compliance, leadership experience, expertise in 21 CFR and GAMP standards, GMP IT oversight, documentation and regulatory interaction skills.
Candel TherapeuticsNASDAQ: CADL: Develops viral immunotherapies for the treatment of cancer.
6+ YOE6+ years QA experience with BS/BA in scientific or engineering (or 8+ years with Associate); knowledge of 21 CFR Part 11/Annex 11/CFR210/211, GxP, eQMS, internal audit, and regulatory guidelines; strong communication and organizational skills.
Electronic Quality Management System (eQMS), SmartSheet, SharePoint, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams