Colleen Geary McClelland
Frederick
Summary
Results-driven Quality Control Specialist with extensive experience at AstraZeneca, excelling in microbiological assays and GMP compliance. Proven track record in mentoring teams and enhancing process efficiency. Adept at data analysis and fostering collaboration, ensuring adherence to quality standards while implementing effective solutions. Committed to continuous improvement and quality assurance.
Overview
10
10
years of professional experience
Work History
Quality Control Specialist I
AstraZeneca Frederick Manufacturing Center
Frederick
09.2024 - Current
- Validates and reviews the quality of materials, water, environment, and finished products in the manufacturing system through various microbiological assays. Mentored analysts as part of a one-on-one training program to improve efficiency and onboarding process. Documents data to confirm compliance with quality standards and those of FDA regulation. Investigates and reports excursions within the environment of the manufacturing area following GMP and GLP practices. Identify, challenge, develop, and implement written procedures, methods, and batch documents.
Quality Control Specialist
AstraZeneca Frederick Manufacturing Center
Frederick
05.2020 - 09.2024
- Samples and tests the quality of raw materials, water, environment, and finished products in a pharmaceutical manufacturing system through various micro-biological assays. Documents data from testing to confirm compliance with quality standards. Ensures all work is conducted in accordance with written procedures, methods, and batch documents. Contributes to departmental quality documentation including SOP’s, batch documentation, validation protocols & reports.
Newborn Hearing Screen Technician
Henrico Doctors Hospital
Richmond
12.2015 - 04.2020
- Conducted initial hearing screens on newborn infants, provided excellent customer service, and maintained detailed records while following strict policies of the hospital and Virginia Health Department.
Supervisor of Newborn Hearing Screens
Henrico Doctor’s Hospital
Richmond
06.2019 - 01.2020
- Participated in the implementation and organization of the newborn hearing screening program. Processed bi-weekly payroll for all hearing screening technicians. Processed billing for all patients receiving hearing screens. Interacted and developed relationships with hospital departments and Program Medical Director to ensure effective level of collaboration.
Education
Bachelor of Arts - Biology (with Honors)
Randolph Macon College
Ashland, VA06.2019
Advanced Diploma - College Preparatory Curriculum
Saint Gertrude High School
Richmond, Virginia05.2015
Skills
- Microbiological assays
- GMP compliance
- Data analysis
- Quality assurance
- Process improvement
- Team collaboration
- Problem solving
- Effective communication
- Six sigma methodologies
- Mentoring others
Volunteer Experience
Church Youth Teacher, Muscular Dystrophy Association, Richmond Sports Backers
Timeline
Quality Control Specialist I
AstraZeneca Frederick Manufacturing Center
09.2024 - Current
Quality Control Specialist
AstraZeneca Frederick Manufacturing Center
05.2020 - 09.2024
Supervisor of Newborn Hearing Screens
Henrico Doctor’s Hospital
06.2019 - 01.2020
Newborn Hearing Screen Technician
Henrico Doctors Hospital
12.2015 - 04.2020
Bachelor of Arts - Biology (with Honors)
Randolph Macon College
Advanced Diploma - College Preparatory Curriculum
Saint Gertrude High School
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