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MilliporeSigma · 2 days ago

Quality Assurance Specialist - QMS & Compliance

Rockville, MD

Full-time

Onsite

Mid Level

$76K/yr - $123K/yr

4+ years exp

MilliporeSigma is a company that innovates with science and technology to enrich lives across Healthcare, Life Science, and Electronics. The Quality Assurance Specialist will conduct audits, review and approve regulated documentation, and act as a subject matter expert in root cause analysis and quality assurance processes.

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

Quality AssuranceRoot Cause AnalysisCAPAGxP EnvironmentFDA RegulationsEU RegulationsAgilityCommunication SkillsInterpersonal SkillsTeam Collaboration

Required

Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assurance within a GxP environment

1+ years' experience with conducting client and/or supplier audits in a Quality Assurance role

1+ years' experience in conducting and/or reviewing root cause analysis and CAPA for deviations and out-of-specification (OOS) results in a Quality Assurance role