Aimee Park
Milford,MA
Summary
Seasoned Quality Control professional with over 18 years at Sanofi, demonstrating exceptional analytical thinking and mentoring skills. Spearheaded technical laboratory investigations, significantly enhancing compliance and process improvement. Proven expertise in QC Chemistry, regulatory audits, and GMP documentation, coupled with a talent for coaching teams towards excellence in operational efficiency.
Overview
19
19
years of professional experience
Work History
Quality Control Chemistry Lab Team Leader
Sanofi
Framingham, USA
12.2020 - Current
- Experience with performing technical laboratory investigations and deviations through Veeva
- 18+ years of QC Chemistry technical background
- Supervises analytical data review compliance team
- On-the-floor managerial experience with QC analysts (provides guidance on daily operations)
- Reviews Quality Control Chemistry assay data for compliance to procedures and specifications
- Participates in regulatory audits (technical expert on QC data and audit trail review)
- Identifies deviations to procedures
- Coordinates with QC/QA/Stability for on-time delivery of data
- Schedules all data reviews against expected turnaround times
- Collaborates with QC management for scheduling of testing/reviews
- Mentors analysts on proper GMP documentation and compliance
- Trains staff on assay review
- Performs 21CFR audit trail review
- Authors revisions to QC procedures
- Archives QC data
- Smart QC scheduling software administrator
- Experience with GEMBA
- Software: Empower, Openlab, Phoretix, OneLIMS, ILIMS, Softmax, APEX, Phenix/Trackwise, QualiPSO
Quality Assurance Principal Compliance Specialist, Lot Disposition
Sanofi
Framingham, USA
07.2016 - 12.2020
- Performed all duties of QC Lab Team Leader
- Performed COA generation/review for final release
- Reviewed revisions to QC procedures as QA representative
Quality Control Analyst I through Principal Analyst
Genzyme Corporation/Sanofi
Framingham, USA
05.2006 - 07.2016
- Performed sample testing and analysis for release, Stability, non-routine, and in-process samples within established turnaround times within a GMP environment
- Managed and performed all Stability and release data compilation
- Conducted peer review and preliminary evaluation of results for compliance to SOP and specification
- Identified potential problems and proactively suggested technical solutions based upon analytical expertise and knowledge of product/processes
- Organized new standard and control preparations
- Managed control/standard inventory for 70 QC methods
- Performed statistical analysis on assay controls and authored qualification reports
- Performed maintenance on laboratory equipment
- Provided training and technical leadership to less experienced staff
- Participated in transfer of methods between laboratories
- Acted as a subject matter expert on various assays within the laboratory (Gel electrophoresis/enzyme kinetics)
- Participated in continuous improvement projects within the laboratory (5S)
- Interacted with external personnel on technical matters requiring coordination between sites
- Prepared reagents
- Coordinated control and standard shipments for international sites
Education
Bachelor of Science - Biology, Pre-medical Concentration, Minor in Chemistry
University of New Haven
West Haven, CT05.2006
Skills
- 18 years technical QC experience
- Complex problem-solving
- Leadership
- Excellent critical thinking skills
- Strict adherence to compliance
- Attention to detail
- Team supervision
- Teamwork and collaboration
- Project management
- Task delegation
- Coaching/Mentoring
- Process improvement
- Flexible schedule
References
Available upon request
Timeline
Quality Control Chemistry Lab Team Leader
Sanofi
12.2020 - Current
Quality Assurance Principal Compliance Specialist, Lot Disposition
Sanofi
07.2016 - 12.2020
Quality Control Analyst I through Principal Analyst
Genzyme Corporation/Sanofi
05.2006 - 07.2016
Bachelor of Science - Biology, Pre-medical Concentration, Minor in Chemistry
University of New Haven
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