Leslie Hubbard Email and Phone Number

Manage, implement, and maintain internal quality systems for all the Development and Operations organization, interacting with the entire organization to achieve quality and compliance initiatives and goals. Communicate quality system improvements, issues and resource requirements to maintain compliance. Support Quality Systems at suppliers, as applicable.

Designed, implemented and owns the Corrective and Preventive Actions (CAPA) program at Gaia Herbs, Inc.• Established, organizes and leads monthly CAPA progress & implementation meetings across five distinct internal departments including production, bottling, warehouse & fulfillment, QC laboratory, and contract manufacturing.• Subject Matter Expert: Failure Investigation, Root Cause Analysis, and Continuous Improvement.• Shifted management reliance on “human error” root cause findings to focus on process, method, environment and equipment improvements across departments to enhance & broaden Gaia’s culture of Quality, and improve CAPA effectiveness outcomes.• Completely overhauled and redesigned production line clearance and pre-run inspection processes, resulting in elimination of line clearance failures on the manufacturing floor.• Championed and implemented the move from 100% manual Quality Inspection of printed materials to state of the art computerized inspection and approval.• Works effectively across departments with diverse teams, from the production floor to Executive suite.• Trains personnel on process improvements arising from CAPA Investigations and Action Plans.• Develops, writes, reviews SOPs to support production and GMP Quality Management Systems.• Supervises Gaia Herbs’ incoming Quality Inspectors for Raw Materials and Packaging & Labels.• Investigates supplier Out-of-Specification events, Deviations, Material Reviews, and process failures to root cause, resolution, and disposition.• Conducts all Effectiveness checks to ensure CAPA improvements were successful.• Reviews and approves packaging component investigations and reprocessing instructions.• Attends daily meetings with cross functional Quality management teams to prioritize workflow.

Plan, conduct and report on internal quality systems audits and external supplier quality audits, foreign and domestic, to support the Argos Supplier Quality program. Provide internal compliance and quality guidance and support. Contribute to multi-departmental teams, intercompany working groups and companywide harmonization efforts in support of the Argos Supplier Quality program.

Develop, implement and maintain internal quality systems, procedures and practices in a GMP manufacturing facility.

Audited and released laboratory reports, batch records, and Certificates of Analysis.Audited and approved laboratory methods and customer protocols for compliance.Conducted monthly internal laboratory cGxP compliance audits. Conducted quarterly internal departmental cGxP compliance audits.Conducted quality systems report reviews, including; Out of Specification and Aberrant/Atypical Data Investigations, Laboratory Error Reports, Deviations, Corrective and Preventative Action Plans and Trackwise Problem Reports.Reviewed reports, raw data and protocols for accuracy, completeness and compliance with internal SOPs and applicable regulatory standards.Compiled Annual Product Review data for commercial product customers.

Reviewed, approved and released laboratory reports, CofA’s, methods and protocols. Conducted monthly internal laboratory audits. Prepared completed data packets for archival.

Coordinated, revised, wrote SOPs, ICPs, IQSs. Primary focus was assisting laboratory staff with document revision and approval procedural tasks.