Kara Faught
Lenoir,NC
Summary
Results-driven certified project manager (PMP) with 10 years of expertise in the pharmaceutical industry and 16 years in biomedical sciences. Skilled in leading cross-functional teams in the development and commercialization of pharmaceutical products. Expertise in managing timelines, resources, and budgets while ensuring strict adherence to regulatory, quality, and clinical standards. Proven track record of driving operational efficiencies and process improvements, helping organizations meet strategic objectives and deliver impactful results.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Pharmaceutical Project Manager
XGen Pharmaceuticals, DJB
Horseheads, NY
12.2023 - Current
- Oversees the development, validation, registration, and submission of pharmaceutical products.
- Develops and maintains project plans, timelines, RAID logs, and minutes.
- Manages project budgets, including forecasting and tracking expenses.
- Communicates effectively with stakeholders to ensure project goals are met on time, and within budget.
- Develops solutions to project risks and issues, meeting quality, and timeline goals and objectives.
- Collaborates closely with senior management on long-term strategic planning initiatives related to projects in development or execution stages.
- Coordinates resources across multiple departments and teams, as needed, for the successful completion of projects.
- Documents all project milestones, tasks, deliverables, and changes related to scope of work.
Project Coordinator
XGen Pharmaceuticals, DJB
Horseheads, NY
05.2022 - 12.2023
- Ensured assigned tasks complied with established project management protocols to achieve successful portfolio growth.
- Executed financial transactions to guarantee accurate and prompt settlement of vendor accounts via established accounting platforms.
- Engaged all stakeholders through continuous and effective communication to build strong professional connections.
- Participated in professional development opportunities to stay current with industry trends and technologies.
- Liaised with project managers to evaluate project scope and define milestones and deadlines.
Senior Batch Record Writer
Exela Pharma Sciences
Lenoir, North Carolina
07.2017 - 05.2022
- Managed the creation and revision of Master Batch Records for new products in accordance with 21 CFR 211.188.
- Liaised with Regulatory Affairs, R&D, Quality Control, Technical Services, Operations, Packaging/Labeling, and Quality Assurance to obtain the information required from Subject Matter Experts and Stakeholders.
- Coordinated and tracked the review and approval of Master Batch Records, and communicated the status of Batch Production Records with Production and Supply Chain.
- Executed change controls, deviations, and CAPAs associated with Master Batch Records.
Batch Record Reviewer
Exela Pharma Sciences
Lenoir, North Carolina
12.2016 - 07.2017
- Performed a critical review and release of executed batch record documentation, and approved executed batch records for final disposition.
- Coordinate corrections and discrepancies with operations personnel.
Quality Assurance Officer
Exela Pharma Sciences
Lenoir, North Carolina
07.2015 - 12.2016
- Provided quality assurance support for all manufacturing activities, and monitored daily pharmaceutical operations, ensuring aseptic filling techniques.
- Conducted operational audits according to standard operating procedures.
- Assisted in identifying and developing Standard Operating Procedures and systems to comply with regulatory requirements..
Histology Manager
Piedmont Pathology Associates
Hickory, North Carolina
05.2014 - 06.2015
- Managed day-to-day operations in histology, performing all phases of routine and special histologic techniques.
- Oversaw the training of all histology staff, assisted with the development, writing, and implementation of all histology policies and procedures.
- Maintained all laboratory equipment. Provided technical support for clients, lab staff, and pathologists.
- Responsible for all compliance standards for CAP and CAP proficiency testing.
- Assured that the Pathology department adhered to all regulatory organization safety, security, and quality standards (CAP, OSHA, CLIA).
Histotechnologist
Mankato Clinic
Mankato, Minnesota
03.2012 - 04.2014
- Assisted in the opening and setup of the laboratory, oversaw, and performed all daily routine laboratory operations.
- Performed all grossing, processing, embedding, sectioning, and staining of specimens.
- Responsible for ordering supplies, monitoring inventory, and ensuring cost efficiency.
- Responsible for maintaining all logs, procedures, and records directly related to quality control and preventative maintenance while ensuring CLIA compliance.
- Assisted in MOHS surgery and the training of nurses in all aspects of the MOHS laboratory.
- Collaborated with the director of the laboratory, dermatopathologists, and pathologists to determine departmental needs.
Education
Bachelor of Science - Biological and Chemical Sciences
Florida Atlantic University
Boca Raton, FL08-2008
Histotechnology (HTL) -
Darton College
Albany, GA05-2012
Skills
- R&D and CMC Project Management
- Project Planning and Development
- C(D)MO, CRO, API Management
- FDA, GMP, ICH Guidance
- Problem Solving and Risk Mitigation
- Aseptic and Terminally Sterilized Manufacturing
- Lyophilization and Liquid Fill Finish
- Multi-Stakeholder Asset Management
- Budget Forecasting and Management
Certification
- Project Management Professional Certification (PMP), Project Management Institute, August 2023
- Histotechnogist Certification (HTL), American Society for Clinical Pathology, July 2014
Timeline
Pharmaceutical Project Manager
XGen Pharmaceuticals, DJB
12.2023 - Current
Project Coordinator
XGen Pharmaceuticals, DJB
05.2022 - 12.2023
Senior Batch Record Writer
Exela Pharma Sciences
07.2017 - 05.2022
Batch Record Reviewer
Exela Pharma Sciences
12.2016 - 07.2017
Quality Assurance Officer
Exela Pharma Sciences
07.2015 - 12.2016
Histology Manager
Piedmont Pathology Associates
05.2014 - 06.2015
Histotechnologist
Mankato Clinic
03.2012 - 04.2014
Bachelor of Science - Biological and Chemical Sciences
Florida Atlantic University
Histotechnology (HTL) -
Darton College
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