Amanda McClendon
Conyers,GA
Summary
Results-driven QC Manager with a proven track record in enhancing laboratory operations and driving quality initiatives. Expertise in sample management, stability, shipping management and process improvement, delivering consistent results in quality assurance.
Overview
32
32
years of professional experience
Work History
QC Manager, Laboratory Operations
Takeda Pharmaceuticals (formerly Shire, Baxalta, and Baxter)
Social Circle, GA
05.2014 - Current
- Actively participating in green lab biopharmaceutical site project development from outset.
- Administered contract laboratory program for company throughout preliminary phases and later for raw materials.
- Trained team members regarding adherence to GxP regulations and inspection standards.
- Created and launched effective sample, shipping, material, and stability management programs within company.
- Oversaw annual management of over 30,000 samples, facilitating more than 500 domestic and international shipments.
- Executed JDE and LabWare systems for inventory tracking of routine, non-routine, and stability samples.
- Led laboratory in 5S certification and participated in the laboratory's Green Lab Certification.
- Contributed to FDA and AGES biennial audits.
Sample Management Director
SciSafe
Cranbury, NJ
12.2010 - 05.2014
- Constructed foundation of biological and pharmaceutical storage facility.
- Established procedures and processes for managing various sample types, including stability, and legal medical devices.
- Coordinated services for close to 100 distinct clients.
- Validated all temperature-controlled units including 3 walk-in stability chambers and 1 walk-in freezer.
- Collaborated with legal firms for secure storage of legal evidence.
- Assisted with FDA audits of the company.
Senior Laboratory Support Administrator
Solvay Pharmaceuticals
Marietta, GA
12.1993 - 06.2009
- Progressed from assistant scientist executing drug product stability analysis via gas chromatography to QA documentation auditor scrutinizing compliance of documents and testing packets with established procedures and GDP guidelines.
- Directed company's stability program while acting as stability administrator for all products. Created innovative temperature-controlled shipment process using thermal couple panels to ensure cold chain integrity.
- Advanced to laboratory support administrator, facilitating daily support for sample, stability, controlled documents, and managing company's DEA substance program.
- Assisted with all DEA audits for the company.
Education
Bachelor of Science - Chemistry, Biology
University of North Georgia
Dahlonega, GA12-1993
Skills
- Strong work ethic
- Teamwork and collaboration
- Attention to detail
- Organizational skills
- Inventory control
- Continuous improvement
- Written communication
- Policy reinforcement
Timeline
QC Manager, Laboratory Operations
Takeda Pharmaceuticals (formerly Shire, Baxalta, and Baxter)
05.2014 - Current
Sample Management Director
SciSafe
12.2010 - 05.2014
Senior Laboratory Support Administrator
Solvay Pharmaceuticals
12.1993 - 06.2009
Bachelor of Science - Chemistry, Biology
University of North Georgia