Investigation & Client Quality Specialist
Core
Ensure consistent execution of quality standards and regulatory compliance in a GMP environment, enabling customers to make breakthrough discoveries.
Role type
Quality Assurance Specialist (Regulatory Compliance & Investigations)
Builds
Quality management systems and compliant product releases for global customers
Domain
Life Sciences / Pharmaceutical / Medical Device
Required skills
cGMP knowledge, ISO standards (13485/9001), quality systems documentation, root cause analysis, internal/external audit support, quality management software (TrackWise, SAP), detailed documentation review, analytical problem solving
Preferred skills
Pharmaceutical sterile/medical device experience, Quality Systems/GMP certifications, Lean/Six Sigma, continuous improvement methodologies
Technologies
TrackWise, SAP, Microsoft Office
Responsibilities
Perform detailed documentation review and quality assessments, conduct internal quality audits and support external regulatory audits, drive continuous improvement initiatives, collaborate with cross-functional teams to maintain quality standards
Seniority
Mid-level, hands-on IC
