Tara Hamilton Email & Phone Number

Durham, North Carolina, Us

- Managed a team of remote training coordinators and specialists responsible for administering company-wide Onboarding and compliance training at 8 global sites- Assisted with the testing, validation, implementation, and continuous improvement of the ComplianceWire Learning Management System- Supported client audits and regulatory inspections (FDA, Belgium Federal Agency for Medicinal and Health Products (FAMHP), and Swissmedic)- Authored and revised department Standard Operating Procedures (SOPs)- Coordinated site-wide training programs, including Annual CGMP Refresher training, Qualified Trainer program, and weekly LMS courses- Collaborated with functional leads to perform needs analysis and implement training strategies- Led the automation of criteria-based training assignments for various departments- Managed Deviations and Corrective and Preventative Actions (CAPAs) for the department

Durham, Nc, Us

- Employed at Tergus Pharma, prior to MedPharm merger - Managed company-wide GMP training program to ensure compliance with Current Good Manufacturing Practices and company procedures- Collaborated with company leadership to develop and implement a comprehensive onboarding and training program- Authored SOPs including SOP-ADM-1001 Personnel Training and WI-ADM-1001 On The Job (OJT) Practices and Procedures- Developed a range of training resources including Train-the-Trainer Certification, Instructor-Led Courses, PowerPoints, Quizzes, and OJTs for Quality Control, Manufacturing, Analytical R&D, Formulation Development and other functional departments- Provided KPIs for inclusion into monthly Quality Council presentations- Obtained external workforce development training grants- Served as ZenQMS Org Admin, assisting with the creation of site-specific architecture and software customization- Revised, formatted, uploaded, routed, and approved training events, employee resumes, SOPs, Forms, protocols, reports, and Quality documents in ZenQMS- Managed the biennial review of GMP documents site wide- Maintained paper-based employee training records in the QA Archives- Issued Quality notebooks, logbooks, and documents- Reviewed and approved laboratory-related Investigations, Deviations, and CAPAs

Raleigh, Nc, Us

- Advanced BioNetwork's statewide mission as the life science training initiative by providing customized training and curriculum development relevant to NC’s second largest employment sectorResponsible for strategic planning of programming including Cell and Gene Therapy, Mammalian Cell Culture, Biomanufacturing, Validation, and Quality Systems- Successfully generated and managed a $1.55 million budget for expenditures such as salaries, equipment, and consumables, resulting in a 98% spend rate- Managed a diverse team of remote and on-site personnel in administrative, manufacturing, laboratory, and training roles- Developed online and hybrid biomanufacturing and pharmaceutical training programs in response to the COVID-19 pandemic- Organized workshops and regional symposiums including“Spotlight on Education,” “Cell and Gene Therapy Symposium and Vendor Show,” and “BioGrow: Training and Education Across North Carolina”- Obtained a NIIMBL grant for retraining military personnel in biomanufacturing in collaboration with Texas A&M University- Fostered partnerships with pharmaceutical companies and the Food and Drug Administration (FDA) - Served on the Advisory Board of NC Biotechnology Center’s Bioprocess Development Group and NC BIO’s Biomanufacturing Forum

Raleigh, Nc, Us

- Developed and delivered customized hands-on industry relevant content in courses for industry clients in CGMP, GDP, Cleanroom Gowning, Aseptic Processing, Upstream/Downstream Processing, Environmental Monitoring, and Single Use Technology - Supervised team of training personnel and ensured cross-training of staff

Henderson, Nc, Us

- Responsible for strategic planning of Bioprocess Technology program, and management of program budget- Maintained a process manufacturing laboratory including HPLC units, Panda homogenizer, lab-scale bioreactors, and lyophilizer- Supervised adjunct faculty, laboratory personnel and work-study students - Taught courses in Bioprocess Tech, Industrial Science and Chemistry- Fostered partnerships with Novozymes, Revlon, Merck, Hospira, KBI Biopharma, and Biogen- Conducted outreach opportunities and hosted summer Biotech Workshops for area elementary, middle and high schools

Henderson, Nc, Us

- Taught Academic Transfer and Occupational Extension courses in Bioprocessing, Industrial Environment and BioWork - Served on Academic Affairs, Safety, and Sustainability committees

Louisburg, Nc, Us

- Managed school wide compliance related to EPA policies as a Small Quantity Hazardous Waste Generator- Facilitated multi-year legacy chemical and hazardous waste disposal

Louisburg, Nc, Us

- Taught Organic Chemistry, General Chemistry, Chemistry for Allied Health, Genetics and Molecular Biology, and Principles of Biology

Durham, North Carolina, Us

• Worked in the laboratory of Vann Bennett, M.D., Ph.D. researching the molecular mechanism of ankyrin-B in cardiomyocytes.• Awarded a National Institutes of Health Ruth L. Kirschstein Postdoctoral Fellowship, 1F32HL080852-01, Principal Investigator, 2005

Lexington, Ky, Us

- Research on secretory mechanisms of platelets

Ludwigshafen, De

- Analyzed batches of super-absorbent polymers

Norfolk, Va, Us

- Investigated effects of trans-resveratrol on sex hormone binding globulin (SHBG) in MCF-7 breast cancer cells

Richland, Wa, Us

Associated Western Universities and Department of Energy Science and Engineering Research (SERS) programs, Pollution Prevention Intern

Ph.D., Biochemistry

Bs, Biochemistry