Wilma Shaw
Chicago,IL
Summary
Experienced Stability Manager with a proven track record in GMP compliance and quality assurance. Skilled in statistical analysis, cross-functional communication, and team leadership, driving operational efficiency and enhancing product quality.
Overview
23
23
years of professional experience
Work History
Stability Manager
Voyant Beauty, LLC
Hodgkins, IL
01.2009 - Current
- Technical writer of all annual product reviews for OTC products for a contract manufacturer of OTC and cosmetic products inclusive of statistical analyses using Minitabs.
- Ensure GMP compliance with all applicable laws, regulations, industry standards, and specifically ICH guidelines.
- Support customer, FDA and ISO audits along with the Quality and Compliance Managers.
- Oversee daily operations, maintaining efficiency and quality standards within the Stability Department, and coordinate activity across the company network across multiple sites within the company network.
- Coordinate cross-functional communication to align departmental goals and objectives with company goals and objectives.
- Train staff on company policies, analytical test methods, good documentation practices and best practices for operational efficiency.
- Maintain up-to-date records of employee attendance, payroll information, vacation requests.
- Assess team member's skillsets and assigned tasks accordingly for optimal efficiency.
- Resolve conflicts between employees by providing guidance on company policies and procedures.
- Facilitate regular team meetings to discuss project updates and address challenges.
- Coach, mentor and train team members in order to improve their job performance.
- Assign tasks to associates to fit skill levels and maximize team performance.
- Conduct regular meetings with staff to discuss progress and identify areas of improvement.
- Create monthly reports for senior management summarizing operational performance metrics.
- Conduct performance evaluations, providing feedback and coaching for team development.
- Attend weekly internal and customer meetings in order to gain insight of new projects/products in order to assess the need for stability testing.
- Revise and update all stability protocols, data reporting templates, Standard Operating Procedures and Work Instructions for the Stability Department for conducting routine laboratory testing the Stability Department (as needed).
- Provide costing invoices to Customer Service for all stability studies.
- Provide customer support in determining appropriate stability testing protocols and intervals based on product type.
- Coordinate Annual Review of OTC Retains.
- Performed OOS, OOT, CAPA and Non-Conforming Product Investigations as needed using QT9 platform.
- Assist staff with analytical testing and data reporting of product on stability as needed using SLIM and other databases.
Stability Coordinator
Voyant Beauty, LLC
Hodgkins, IL
01.2006 - 01.2009
- Initiated stability testing of all OTC and Cosmetic products with R&D Chemists and/or customers via generating stability protocols
- Trained and supervised activities of all stability personnel to be in compliance with ICH, internal guidelines as well as customer-specific guidelines for stability testing.
- Manage day-to-day operations of the department including scheduling tasks and assigning duties.
- Pull and/or tested stability samples as needed in order to assist Stability Chemists and Technicians inclusive of both physical( color, odor, appearance, pH, viscosity, specific gravity, % solids, refractive index) and chemical testing via GC and HPLC.
- Maintain records of all stability-related activities.
- Performed Customer Complaint Investigations and reported findings to customers.
- Performed OOS, OOT, CAPA and Non-Conforming Product Investigations as needed.
- Attended weekly New Products Meetings in order to gain insight of new customer projects in order to assess the need for stability testing.
- Delegated work to staff, setting priorities and goals.
- Trained employees on best practices and protocols while managing teams to maintain optimal productivity.
- Reviewed employees' work to check adherence to quality standards and proper procedures.
- Trained and supervised activities of all stability personnel to be in compliance with ICH, internal guidelines as well as customer-specific guidelines for stability testing.
- Coordinated the testing of stability samples with Analytical, Microbiology & R&D Managers for the timely reporting of data to customers.
- Coordinated stability chamber calibration and maintenance with Maintenance Dept, Engineering Department and/or Contractors.
- Technical writer for all customer Annual Drug Product Reviews for OTC products.
- Coordinated personnel with the annual review of all OTC retains.
- Wrote/maintained all work Instructions and Standard Operating Procedures for the Stability Department.
- Monitored and maintained environmental monitoring devices throughout warehouse and in stability chambers via weekly temperature/humidity trending.
Senior Analytical Chemist
VeePak Inc(now Voyant Beauty, LLC)
Chicago, Illinois
03.2003 - 01.2006
- Conducted physical and chemical analysis of raw materials and finished product using Infrared Spectroscopy, pH meter, viscometer, rheometer, Karl Fisher Moisture, vacuum oven, densitometer, pycnometer, chromatography (HPLC and GC) and titrations per USP procedures using GMPs and GLPs.
- Trained junior staff on laboratory techniques and safety protocols.
- Documented all procedures and results in detailed laboratory notebooks.
- Tested in-process batches and gave routine batch adjustments as needed.
- Witnessed addition of actives into batches.
- Issued approval, rejection, hold or transfer tags for batches to be used for production.
- Tested finished product at line start up samples and at beginning, middle, and end of production runs.
- Followed and observed batch transfer procedure.
- Tested and receive incoming raw material tankers.
- Maintained and calibrated test equipment per schedule.
Education
Bachelor of Science - Cheistry
Xavier University of Louisiana
New Orleans, LA05-1992
Skills
- Statistical analysis
- GMP compliance
- Stability testing protocols
- Cross-functional communication
- Quality assurance
- Customer relationship management
- Auditing support
- Performance evaluation
- Schedule preparation
- Trend analysis
- Verbal and written communication
- Clear communication
- Staff management
- Documentation and reporting
- Complex Problem-solving
- Time management
- Performance evaluations
- Coaching and mentoring
- Policy and procedure development
- Staff training and development
- Team leadership
- Task delegation
References
References available upon request.
Timeline
Stability Manager
Voyant Beauty, LLC
01.2009 - Current
Stability Coordinator
Voyant Beauty, LLC
01.2006 - 01.2009
Senior Analytical Chemist
VeePak Inc(now Voyant Beauty, LLC)
03.2003 - 01.2006
Bachelor of Science - Cheistry
Xavier University of Louisiana