Owner and Operator of a Vape Store. Responsibilities included Customer Service, Budgeting, Bookkeeping, Inventory Management, Ordering, Advertising, Supervising Employees, and Scheduling. Ensuring adherence to Local, State, Federal, OSHA and FDA guidelines for product compliance, advertising, customer sales and employees well-being.

Helped Create a data review group that reviewed all data for the analytical services group including Raw Material Release, In-process, Final Product and Stability testing. Ensure cGMP compliance, adherence to SOP, and Training documentation. Coordinated with Manufacturing, Metrology, Analysts, Supervisors and Senior Management to ensure timely release of Raw Materials, in-Process Buffers and Final Product. Reviewed Analytical Equipment Validation. Setup data archive procedures for Stability and provided FDA Inspection support.

Provided analytical support for production site including Stability testing, raw material release, in-process testing and release testing.

Training to be a quality supervisor in a Plasma Center. Responsible for ensuring adherence to FDA guidelines in all center operations. Including employee performance review, chart and equipment log review. Accept incoming materials and release raw materials for shipment.

Continued equipment life cycle support and expanded responsibilities doubling workload while training new personal. Areas of responsibility were able to complete maintenance and validation projects on time. As Team Lead I mentored co-workers and supervised lab assistant enabling team to meet departmental goals. Become point of contact for our team and provided guidance in cGMP applications as they pertained to equipment management.

Quality Equipment Management, processed over 1000 work orders for over 200 pieces of equipment annually. Vendor Management, and service contracts. Attention to detail with timely documentation and accurate review of validation protocols, maintenance and peer review prevented potential compliance risk.

Coordinated equipment life cycle for CRS and non-CRS lab equipment under GLP guidelines. Collaboration with analysts, metrology, and vendors ensured minimal downtime and enabled labs to meet sample timelines and product release dates.

Provided In-Process analytical lab support for Commercial Manufactruing production and purification processes. Under manufacturing timelines set-up assays, analyzed samples, and completed data write-up under critical timelines. Performed Stability testing as needed and Coordinated procurement of new equipment, transferred new assays into the lab, set-up routine operating procedures for the lab to ensure GLP compliance, a state of readiness and real-time support for manufacturing.

Provided real time in-process and batch release analytical support for Clinical Manufacturing production ad purification. Set up, ran and coordinated all operations of the analytical lab. Well organized and thorough understanding of the processes enabled me to continue to be the sole analytical support for Clinical Manufacturing even after a 200% increase in production.