Suseth Sierra
Irvine,CA
Summary
Results-driven manufacturing professional with deep expertise in Lean implementation, GMP compliance, and batch record management. Adept at designing and executing process improvements that boost productivity, enhance safety, and reduce waste. Highly regarded for exceptional time management, strategic problem-solving, and the ability to rapidly master and deploy new skills. A reliable, adaptable team leader committed to driving operational excellence, empowering colleagues through targeted training, and consistently delivering measurable gains in quality and efficiency.
Overview
11
11
years of professional experience
Work History
PLANNING DEPARTMENT
Bio-Rad
Irvine, CA
10.2022 - 03.2025
- Managed the printing and distribution of batch records for RMP, CAP, FILL, and Formulation departments, ensuring strict adherence to compliance and regulatory standards.
- Partnered with engineering and cross-functional teams to update documentation in alignment with evolving process requirements and industry benchmarks.
- Compiled and analyzed quarterly reports on product date extensions, enhancing inventory management and significantly reducing material waste.
- Verified certifications and quantities for incoming plasma and raw materials, ensuring quality standards and compliance with regulatory guidelines.
MANUFACTURING TECHNICIAN 1
Bio-Rad
Irvine, CA
09.2019 - 10.2022
- Entrusted to design and implement Lean manufacturing and packaging processes focused on improving operational efficiency and elevating workplace safety standards.Entrusted with creating
- Conducted in-depth testing and analysis to validate process enhancements, leading to measurable productivity gains.
- Led comprehensive training sessions for staff to ensure successful adoption and adherence to newly implemented procedures.
- Supervised the newly established Lean production line, which became the department’s top-performing line, delivering the highest output levels.
MANUFACTURING ASSOCIATE 3
Bio-Rad
Irvine, CA
09.2014 - 04.2019
- Independently set up, operated, maintained, and adjusted manufacturing equipment to ensure optimal production efficiency and product quality.
- Verified and accurately counted components prior to production runs to ensure consistency and compliance.
- Interpreted and completed all necessary manufacturing documentation, including labels, logbooks, and production batch records.
- Performed precise metric-based calculations for batch processing, including loss determination, yield analysis, and reconciliation.
- Ensured adherence to product specifications and quality standards throughout the manufacturing process.
- Trained and mentored new and current manufacturing team members, promoting operational consistency and safety.
- Monitored the production area for safety hazards and strictly followed PPE protocols in line with company safety procedures and SOPs.
- Provided clear, compliant documentation of manufacturing processes, including detailed explanations for any corrections made.
- Evaluated equipment and operational procedures, recommending improvements to enhance productivity and efficiency.
Education
Certified Program - Airline Travel Specialist
International Air And Hospitality Academy
Vancouver, WA05.2009
Skills
- Batch Record Documentation
- Proficient in SAP System
- GMP (Good Manufacturing Practice) Certified
- Machinery Assembly & Maintenance
- In-depth Knowledge of Manufacturing Methodologies & Quality Control
- Strong Understanding of FDA Drug Safety Guidelines
Timeline
PLANNING DEPARTMENT
Bio-Rad
10.2022 - 03.2025
MANUFACTURING TECHNICIAN 1
Bio-Rad
09.2019 - 10.2022
MANUFACTURING ASSOCIATE 3
Bio-Rad
09.2014 - 04.2019
Certified Program - Airline Travel Specialist
International Air And Hospitality Academy