A.hall
Rocklin,CA
Summary
Accomplished Quality Assurance Specialist with a proven track record at MilliporeSigma, enhancing QMS compliance and leading process improvements. Expert in TrackWise, with a knack for cross-functional collaboration and a solid foundation in molecular biology. Demonstrated success in audit coordination and CAPA, significantly improving operational efficiency.
Overview
8
8
years of professional experience
Work History
Quality Assurance Specialist I
MilliporeSigma
03.2024 - Current
- Ensured ISO 9001:2015 QMS compliance, managing the Quality Records system (TrackWise).
- Led customer complaint investigations, collaborating with cross-functional teams.
- Acted as Site Lead User for TrackWise modules, ensuring timely processing.
- Coordinated external and internal QMS audits.
- Analyzed metrics and facilitated monthly review meetings.
- Led critical investigations (OOS, CAPA, RCA, Change Controls).
- Developed and standardized SOPs, Work Instructions, and Forms.
- Monitored production floors and QC labs for quality issues.
- Led process improvement initiatives.
Manufacturing Associate II
Twist Bioscience
10.2019 - 05.2023
- Produced personalized oligo-infused items in a high-capacity manufacturing lab.
- Managed batch records and adhered to GMP standards.
- Conducted quality control and maintained clean rooms.
- Utilized skills in molecular biology, DNA quantification, cell culture, and aseptic techniques.
- Ensured accurate data entry and organization of work instructions.
- Participated in problem-solving and process improvement initiatives.
Pharmaceutical Materials Specialist
Genentech
11.2016 - 10.2019
- Managed inventory, raw materials, and components in a GMP warehouse.
- Developed material demand plans and improved quality control.
- Ensured GMP accuracy and adherence.
- Monitored inventory storage for safe and efficient material movement.
Education
High School Diploma -
Fairfield-Suisun Adult School
Fairfield, CA05-2005
Skills
- Quality Management Systems (QMS)
- TrackWise Proficiency
- Customer Complaint Management
- Root Cause Analysis (RCA)
- Corrective and Preventive Actions (CAPA)
- Process Improvement
- Audit Coordination
- Data Analysis
- Cross-functional Collaboration
- Molecular Biology
- GMP Compliance
Timeline
Quality Assurance Specialist I
MilliporeSigma
03.2024 - Current
Manufacturing Associate II
Twist Bioscience
10.2019 - 05.2023
Pharmaceutical Materials Specialist
Genentech
11.2016 - 10.2019
High School Diploma -
Fairfield-Suisun Adult School
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