Amanda Heavlow - Smoak

Foster a quality culture that drives continuous improvement and positive initiatives to improve efficiency, effectiveness, and compliance.  Continually review and ensure all laboratory activities adhere to necessary GMP, and other regulatory compliance.  Data Management: timely review of all records to maintain timely reporting to clients. o Ensure all documentation follows all aspects of GDocP and ALCOA+ o Established a robust QMS  Inventory Management: approval of vendors, laboratory supplies, and disposal of all material. Maintaining an organized system to track and manage all COA’s and SDS’s for all organisms, media, and chemicals.  Procedural: Ensuring all laboratory testing methods adhere to GMP regulations and guidelines and coincide with most current standard and regulatory methods. o Identify any gaps in processes or documentation  Document Manaagement: Initialize, update, create any necessary documents used for all areas of testing, quality control, and general laboratory maintenance to meet regulatory compliance status. o Maintain comprehensive tracking for all quality functions: change controls, investigations, events, CAPA’s, and deviations o Maintain 500+ documents Training: Implemented a training program focused on GMP guidelines, maintain a constant state of knowledge sharing of current regulatory changes and trends and incorporating those into company’s policies and procedures.  Equipment Management: Establishing a cleaning and maintenance schedule for all laboratory equipment, ensuring all equipment follows an established calibration and validation schedule, proper installation and qualification of all lab equipment.  Audits & Inspections: Ensure laboratory is in an audit ready state, respond to inspections, audits, and other regulatory observations by updating SOPs, creating CAPA’s, or initializing new procedures that rectify the observation. o Respond and update to any FDA Observations & Warning letters

General Microbial Testing and Research

Small mother & daughter business deliver quality handmade gifts, home décor, pet products, jewelry, art and more. Established a consignment for other fellow artisans that do not have the ability or volume to sell things on their own. Partnered with TeamFOX for Parkinson's Research for 5 years. Work with various charities and shelters or rescues to donate pet beds and toys to local animal shelters. Member of Kiwanis Club of Media. (2020-2021) Donate to various charities and organizations for disadvantaged and displaced children. If you are in interested in how we can help you organization or shelter, please reach out. We are passionate about giving back to our community.

General Biology Lab Duties as work study student at DCCC such as Lab set up, biological material preparation and equipment maintenance.

design and general contracting duties

Manage, Process and ensure accuracy of all pCRF's before they are sent off-site. Scan and File study documents.