Project and Product Manager, Compliance SME
- Location
- United States
- Rate, USD
- $90 / hour
- Work schedule
- Contract,
- Language skills
- English
About me
Quality Compliance professional with experience in Quality Audits, Product Project Management, CMC document review, and Quality Risk Management. Also, experienced in management of non-conformance compliance, audit procedures, instituting permanent inspection readiness, and project management. Consultant for aseptic processing, engineering process improvements, and quality planning. Risk-based quality practices that are aligned with regulatory requirements and internal quality standards. Focused on meeting compliance objectives and client needs.
Professional area
Skills
Active ListeningBilingualChange ManagementClient ManagementCoachingCommunication skillsComplianceConsultingDiversity and InclusionEmployee TrainingInternational communicationLeadershipMicrosoft SuiteOnboardingOperations ManagementOrganizational SkillsPeople ManagementPerformance ManagementProblem SolvingProcess ImprovementProcess OptimizationProduct ManagementProject ManagementQuality AssuranceRisk ManagementStrategic ThinkingTeam BuildingTeam ManagementTechnical WritingTranslating
Education
- 2021/2022 Master of Science @ University of California San Diego
Biotechnology: Drug Development and Product Management
- 2019/2021 Bachelor of Science @ MiraCosta College
Biotechnology Manufacturing
- 2015-2017 Associates of Science @ San Diego City College
Associates in Biology
Experience
- 2022/Current Sr. QA/RA Compliance Specialist @ BioSaRCS Corp
Consultant to CDMOs on Compliance, QA and RA needs. Lead projects based on company needs. Biotech manufacturing, vaccine manufacturing, and medical device companies.
- 2021/2022 Sr. Compliance Lead @ Cue Health Inc
Lead of compliance department. Reduced turn around times for product disposition and client complaint compliance.
- 2016/2021 Compliance Specialist @ MilliporeSigma
Tech Ops compliance specialist. Deviation investigations technical writer and CAPA management, process improvement lead, and change control management.
- 2014/2016 QA Specialist @ Alere Inc
CAPA and change control specialist. Technical writer for procedure improvements for Quality Control, Product Development and Manufacturing.
- 2013/2014 Lab Technician @ Verenium
Lab technician, procurement management, maintenance of automated equipment, maintenance of bio-library.
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