MilliporeSigma · 12 hours ago
Quality Assurance Specialist 3
Rockville, MD
Full-time
Onsite
Mid Level
$76K/yr - $123K/yr
4+ years expMilliporeSigma is a global leader in science and technology, dedicated to enriching lives through innovative solutions in Healthcare, Life Science, and Electronics. The Quality Assurance Specialist 3 role involves conducting audits, reviewing and approving regulated documentation, and providing mentorship in quality processes. This position also entails supporting regulatory inspections and authoring standard operating procedures.
BiotechnologyMedicalMedical Device
No H1B
Responsibilities
Review and approve RCA analysis for robustness and accuracy and/or Perform robust RCA using various RCA tools and act as the Subject Matter Expert for RCA
Train and/or provide peer mentorship in the rootcause Investigative Process and techniques
Analyze and evaluate information captured through investigations, communicate findings and recommendations Review and approve OOS, trend, critical-impact deviations and lower impact deviations and conduct trend analysis for deviations
Review / approve applicable CAPA records and conduct Effectiveness checks
Review and approve change control (GCC) records
Train Quality Specialists and/or Operations teams on quality topics. Perform client audits and supplier audits and review and approve client and supplier quality agreements
Provide support for regulatory inspections and for client regulatory submissions
Act as Quality SME during regulatory inspections and customer audits for areas of expertise
Conduct laboratory inspections to include commissioning and/or internal audits
Author, review and approve standard operating procedures (SOPs), quality policy documents
May review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records
May 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
May review and approve validation files for systems and assays
Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics
May perform risk assessment using various methodologies
Qualification
Required
Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in quality within a GxP environment
Associate Degree in Biology, Chemistry, Engineering, or other scientific field with 6+ years' experience in quality within a GxP or regulated field
High School Diploma or GED with 8+ years' experience in quality within a GxP or regulated field
Preferred
Experience with root cause analysis
Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)
Excellent communication and interpersonal skills
Ensures quality of own work in an ethical manner
Open-minded, flexible and works with agility
Meets assigned deadlines
Works with cross-functional teams and builds networks within QA and Operations departments
Collaborates with various teams to identify and implement improvements
Willing to embrace and implement change on a global scale
Benefits
Health insurance
Paid time off (PTO)
Retirement contributions
Other perquisites
Company
MilliporeSigma
Together with our colleagues, customers and stakeholders, we impact life and health with science.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
David Nogales
Head of Technology Strategy
Recent News
2025-09-23
2025-06-20
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