Leanne Kisicki
Athenex Pharma Solutions
Elma,NY
18
years of professional experience
Experienced Quality Director working with customers, employees and changes in business needs. Excellent reputation for resolving problems, improving customer satisfaction, detailed auditor and driving overall quality improvements. Consistently saved costs by 35% while increasing profits by 43%. Seeking a Quality Auditor position with a company to make a positive quality impact on customer service and team productivity.
Work History
Quality Control Director
8 Years 5 Months- Established Chemistry, Microbiology, Incoming Quality Control Departments
- Oversaw over 30 employees
- Quality Control Department representative in FDA and customer audits
- Performed annual reviews
- Managing day to day activities, including raw material, finished good, and stability testing. Increased schedule adherence to 97% monthly
- Wrote initial procedures and company polices for business startup
- Actively update processes based on best practices and change in customer needs
- Train new staff on quality systems,
- Manage quality assurance programs including on site evaluations, internal audits and customer surveys
- Perform daily inspection rounds throughout facilities to check on all equipment and machinery
- Work with outside vendors to ensure state and federal compliance. Was able to save company over $1.36M in negotiations with vendors
- Perform risk assessments for department lean initiatives and better flow process
- Perform monthly department metrics and monthly department budget. Perform assessments based on previous month data
- Perform review and approval of quality investigations, Correction Action Preventive Action, environmental excursions and product batch records
Quality Control Supervisor
3 Years 9 Months- Daily scheduling of laboratory testing and product development projects
- Performed 11 QC staff annual reviews
- Managed recruitment and hiring of new employees
- Reviewed customer interactions and activity reports to identify and address concerns
- Promoted company in maintaining work environment focused on quality, communication, collaboration, integration and teamwork
- Represented Quality Control Department at daily operation meeting. 100% operation schedule adherence
- Established product specifications and quality assurance practices
- Recorded, analyzed and distributed statistical information
- Estimated financial requirements of new projects
- Developed work-flow charts and diagrams to ensure production team compliance with client deadlines
Associate Scientist, Quality Control Analyst
6 Years- Performed analytical testing for finished product group
- Gained advanced knowledge in HPLC, GC, UV-Vis, distillation, pH, IR, wet chemistry testing
- Adhered to written procedures and FDA guidance (USP, ICH and CFR 210 and 211)
- Coached and mentored over 14 junior analysts, provided guidance on assay development and execution
- Prioritized workload with Quality Control team based on needs of Operation Department
Education
Bachelor of Science - Forensic Chemistry
Skills
Quality Management
Teamwork/Collaboration
Customer service-oriented
Strong multi-tasking
decision-making
Meticulously detail-oriented
Goal-oriented
Great communication skills
Root Cause Analysis and Process Improvement
Adherence to quality guidelines
Strong quality inspection and control processes
Great Organization Skills
Word Processing knowledge: Word
Excel
Power Point and Project
Timeline
Quality Control Director
Athenex Pharma Solutions
12.2010 - 05.2019Read More
Quality Control Supervisor
Contract Pharmaceuticals Limited
03.2007 - 12.2010Read More
Associate Scientist, Quality Control Analyst
American Pharmaceutical Partners
03.2001 - 03.2007Read More
State University of New York College At Buffalo
Bachelor of Science from Forensic Chemistry
Read More