Suzanne Lu
Hoover,AL
Summary
Experienced professional with over 15 years of industry expertise in cGMP, electronic Quality Management Systems (eQMS), QC laboratory, and manufacturing. Demonstrated skills in clinical and commercial products, encompassing a diverse range of pharmaceutical/dosage forms including solid dose, sterile products, and medical device. Seeking opportunities to leverage technical and supervisory aptitude acquired through years of experience.
Overview
21
21
years of professional experience
Work History
QA Manager, GMP Operations (Remote)
BioCryst Pharmaceuticals
03.2021 - 01.2025
- Direct junior level team of 3 persons
- Experience with working with various regional partners/markets (EU, Japan, Canada, Turkey, Brazil)
- Experience with working with Qualified Person for market release
- Support external vendor site for any Regulatory agency/Health Authority inspections that pertain to company’s product
- Ensure all aspects of Quality Management at cGMP external vendors are carried out according to cGMP regulations and local regulatory requirements in a phase appropriate approach
- QA support for deviations, investigations, document control, training, validation, internal and external audits, vendor management, stability program
- Conduct, review and/or approve deviations/investigations at external vendors
- Manage/own external change controls and deviations within eQMS (Veeva)
- Review cGMP documentation, including, but not limited to master and executed batch records, associated with drug product, drug substance, packaging and labeling
- Internal batch disposition of drug substance, drug product and packaged/labeled product for clinical and commercial distribution
- Perform disposition of material received at 3PL warehouse (Starting Materials, Drug Substance, and/or Finished Goods)
- Coordinate with internal cross-functional teams such as CMC analytical/technical, MS&T, Supply Chain, Regulatory, and Procurement
- Identify potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation
- Prepare and present batch disposition and external change controls metrics for tracking and trending to Quality management
- Attend cross-functional team meetings and provides guidance to QA staff based on interpretation of current regulations to ensure best practices including risk-based management
- Experience with reviewing, updating and creating SOPs as needed
- Engage in the budget planning process for QA
- Review Quality Agreements and Annual Product Quality Review (APQR)
Quality Assurance Specialist (On-site/Remote)
BioCryst Pharmaceuticals
11.2017 - 03.2021
- Conduct disposition of drug product and packaged/labeled product for clinical and commercial distribution
- Provide quality guidance in the resolution of deviations, investigation, and OOS events
- Review and approve deviations and investigations
- Review of cGMP documentation, including but not limited to master and executed batch records associated with drug product, drug substance, packaging, and labeling as well as process validation protocols and reports
- Review of Quality Agreements and commercial artwork proofs and package insert (labels, printed variable text, barcode information)
- Participate in internal and external program team meetings
- Write and review SOPs and QA procedures
- Assist in preparation and performance of internal audits
- Collaborate with multiple departments such as Supply Chain, CMC, and Regulatory
- Active role in company’s first Phase III OSD to commercial launch
Supervisor, QCL Microbiology
Evonik Corp
09.2017 - 11.2017
- Direct junior level team of 3 employees
- Conduct overseeing and scheduling work activities
- Conduct troubleshooting and resolving day to day issues
Scientist, QCL Microbiology
Evonik Corp
07.2009 - 09.2017
- Collaborative interaction with other functional groups (QA, QC, Manufacturing, Product Development, Procurement, Project Management, Shipping and Receiving)
- Conduct developing and validating new analytical procedures
- Technical lead for bioburden testing
- Support for data trending and lab OOS investigations (TrackWise)
- Conduct submission of samples to external contract labs
- Create, revise, and/or review SOPs, test methods, specifications, forms, stability protocols, and analytical reports
- Conduct peer review of data in preparation for QA review
- Conduct equipment qualification, including protocol drafting, execution, and report generation
- Conduct training junior level staff and GDP training to all employees at site
Scientist, Product Development
Evonik Corp
02.2007 - 07.2009
- Preparation of controlled release microparticles using o/w emulsion techniques
- Preparation of controlled release implants using extrusion techniques
- Analytical characterization of formulations – TGA, DSC, Particle Size, In Vitro Dissolution, Solubility, API extraction
- Experience with biomaterials
- Peer review of analytical data, compilation of reports
Serum Protein Electrophoresis Technician
BioLife Plasma Services
04.2006 - 02.2007
- Analysis of human blood serum for 5 protein fractions
- Review of analytical data in preparation for QA review
Chemist
Severn Trent Laboratories
08.2003 - 09.2005
- GC analysis of soil and liquid samples according to EPA standards
- Peer review of analytical data in preparation for QA review
- Perform preventative maintenance on GC units
Education
Bachelor of Science - Biology
Spring Hill College
Mobile, AL05.2003
Skills
- Adaptability
- Collaboration
- Attention to detail
- Efficient Time Management
- Effective Communication
- Cross-functional team player
- Strong work ethic
- Integrity
Timeline
QA Manager, GMP Operations (Remote)
BioCryst Pharmaceuticals
03.2021 - 01.2025
Quality Assurance Specialist (On-site/Remote)
BioCryst Pharmaceuticals
11.2017 - 03.2021
Supervisor, QCL Microbiology
Evonik Corp
09.2017 - 11.2017
Scientist, QCL Microbiology
Evonik Corp
07.2009 - 09.2017
Scientist, Product Development
Evonik Corp
02.2007 - 07.2009
Serum Protein Electrophoresis Technician
BioLife Plasma Services
04.2006 - 02.2007
Chemist
Severn Trent Laboratories
08.2003 - 09.2005
Bachelor of Science - Biology
Spring Hill College
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