09/24/2026 updated
100 % available
Quality Assurance Specialist | QMS | FDA Regulatory Compliance | Biotechnology
San Diego, USA
Only remote
Master of Science in Pharmacogenomics and Personalized Healthcare, University of CincinnatiGood Manufacturing PracticesComplianceISO 13485Code of Federal Regulations
Quality Assurance & Compliance
Expertise in Quality Assurance, Quality Management Systems (QMS), and FDA Regulatory Compliance including 361 designations. Proven track record of building and scaling comprehensive quality programs for emerging biotechnology companies, ensuring strict adherence to regulatory standards.
Batch & QC Record Review
Extensive experience in conducting rigorous Batch Record and QC Test Record reviews to guarantee product integrity. Authorization of verification, release, and shipment of final products and raw materials to clients.
Document Control & SOP Management
Comprehensive handling of Document Control processes and Standard Operating Procedure (SOP) libraries. Authoring, editing, and standardizing SOPs across multiple departments to ensure operational consistency and regulatory compliance.
Environmental Monitoring
Development and implementation of Environmental Monitoring Programs for biotechnology facilities, ensuring compliance with ISO Cleanroom Operations and aseptic technique requirements.
Equipment Validation & Product Qualification
Evaluation and approval of Qualification Assays and Equipment Validations to ensure compliance with stringent quality thresholds, including facilitation of product validations and equipment qualifications.
GMP Material Inventory Management
Overhauling and managing GMP Material inventory management systems to significantly improve operational efficiency and material coordination across teams.
Vendor & Contract Management
Restructuring Vendor Programs to ensure strict documentation compliance for current vendors and facilitating efficient onboarding of new suppliers. Leveraging professional networking to establish vital contracts.
Training Program Development
Modernizing and streamlining enterprise Training Programs by integrating electronic and hard copy file systems. Conducting intensive staff retraining programs focusing on critical skills including gowning, aseptic technique, equipment handling, and proper documentation.
Microbiology & Laboratory Testing
Management of evening laboratory operations and execution of QC testing for product release. Utilization of advanced testing methodologies including Vidas, TEMPO, and Sterility Testing.
Expertise in Quality Assurance, Quality Management Systems (QMS), and FDA Regulatory Compliance including 361 designations. Proven track record of building and scaling comprehensive quality programs for emerging biotechnology companies, ensuring strict adherence to regulatory standards.
Batch & QC Record Review
Extensive experience in conducting rigorous Batch Record and QC Test Record reviews to guarantee product integrity. Authorization of verification, release, and shipment of final products and raw materials to clients.
Document Control & SOP Management
Comprehensive handling of Document Control processes and Standard Operating Procedure (SOP) libraries. Authoring, editing, and standardizing SOPs across multiple departments to ensure operational consistency and regulatory compliance.
Environmental Monitoring
Development and implementation of Environmental Monitoring Programs for biotechnology facilities, ensuring compliance with ISO Cleanroom Operations and aseptic technique requirements.
Equipment Validation & Product Qualification
Evaluation and approval of Qualification Assays and Equipment Validations to ensure compliance with stringent quality thresholds, including facilitation of product validations and equipment qualifications.
GMP Material Inventory Management
Overhauling and managing GMP Material inventory management systems to significantly improve operational efficiency and material coordination across teams.
Vendor & Contract Management
Restructuring Vendor Programs to ensure strict documentation compliance for current vendors and facilitating efficient onboarding of new suppliers. Leveraging professional networking to establish vital contracts.
Training Program Development
Modernizing and streamlining enterprise Training Programs by integrating electronic and hard copy file systems. Conducting intensive staff retraining programs focusing on critical skills including gowning, aseptic technique, equipment handling, and proper documentation.
Microbiology & Laboratory Testing
Management of evening laboratory operations and execution of QC testing for product release. Utilization of advanced testing methodologies including Vidas, TEMPO, and Sterility Testing.
Experience
Professional experience5 - 10 years
Freelancer since2026
Languages
EnglishNative speaker
Project history
Modernized and streamlined the enterprise Training Program by integrating electronic and hard copy file systems. Overhauled the GMP Material inventory management system, improving operational efficiency. Restructured the Vendor Program to ensure documentation compliance and efficient onboarding of new suppliers. Conducted rigorous Batch Record and QC Test Record reviews to guarantee product integrity and regulatory adherence.
Designed, implemented, and managed a proactive Quality on the Floor program, reducing manufacturing deviations and providing real-time quality support to the production team. Directed comprehensive handling, tracking, and review of Batch Records across multiple clients. Evaluated and approved Qualification Assays and Equipment Validations. Authorized verification, release, and shipment of final products and raw materials to clients.
Engineered processing protocols and detailed work instructions for a novel Cord Blood Derived Biologic product. Spearheaded the development and implementation of the facility's Environmental Monitoring Program. Drafted and submitted strategic proposals to secure FDA approval for 361 designations on Biologics products. Identified and rectified critical bottlenecks in Quality Systems, streamlining the donor eligibility establishment process. Facilitated product validations and equipment qualifications while serving as Acting Laboratory Manager.