Janelle McClinton
Vacaville
Summary
Dynamic Senior Manufacturing Associate with BioMarin, skilled in biopharmaceutical manufacturing and process optimization. Proven ability to enhance workflows and ensure compliance with cGMP standards. Adept at equipment maintenance and fostering team collaboration, I excel in problem-solving and documentation practices to drive operational excellence.
Overview
12
12
years of professional experience
Work History
Senior Manufacturing Associate Cell Culture
BioMarin
Novato
01.2015 - Current
- Demonstrated comprehensive understanding of process theory and biopharmaceutical manufacturing operations.
- Operated in cell culture, production, and protein harvest with a broad scientific and compliance knowledge.
- Supported process optimization initiatives through identification and resolution of processing issues.
- Maintained automation systems (LIMS, MES, PI) to enhance operational efficiency.
- Provided constructive feedback on operational procedures to improve processes.
- Assisted in integrating new technologies and standards into existing procedures.
- Reviewed and authored process documents as a GW CC NDT reviewer.
- Ensured adherence to cGMPs and compliance with training requirements.
Pharmaceutical Tech at Janssen Pharm
Kelly Services
Vacaville
02.2014 - 01.2015
- Adhered to standard operating procedures regulated by FDA, DEA, cGMP, OSHA, and EPA.
- Performed daily cleaning, back-to-back cleanings, and full cleaning in production areas.
- Conducted scale verifications for accurate measurement of raw medication materials.
- Reviewed logbooks for accuracy and completeness to maintain compliance.
- Prepared lots for Tylenol PM, Canagliflozin, and Sudafed, including material verification and documentation.
- Ensured compliance with PPE requirements for all processes involving medication handling.
- Executed milling and charging of medication ingredients efficiently.
- Participated in validation of new equipment cleaning procedures and medication manufacturing.
Education
Associates Degree - Health Care Administration
University of Phoenix
Fairfield, CA03.2013
Skills
- Biopharmaceutical manufacturing
- Process optimization
- Equipment maintenance
- Aseptic technique
- Quality systems
- Compliance adherence
- Workflow optimization
- Problem solving
- Process validation
- Attention to detail
- Effective communication
- Adaptability
- Microsoft Office suite proficiency
- Scheduling and training coordination
- CPR certification
- Mental health support
- Data analysis and reporting
- Problem solving skills
- Team collaboration
- Independent work capabilities
- Documentation practices
Timeline
Senior Manufacturing Associate Cell Culture
BioMarin
01.2015 - Current
Pharmaceutical Tech at Janssen Pharm
Kelly Services
02.2014 - 01.2015
Associates Degree - Health Care Administration
University of Phoenix
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