Allison Westlake is an experienced quality assurance professional with more than 12 years in the pharmaceutical industry. She is a skilled auditor, technical writer, and certified trainer. Her project management skills have generated increased compliance and improved efficiencies in a number of Quality departments. With excellent communication skills, and her education, training, and work experience, Allison is a valued team member who can also work independently as needed to move a project forward. Previous employers include GlaxoSmithKline Canada Inc., Zeneca Bioproducts, Standard Biological Labs (SGS), Whitehall Laboratories, McCain Refrigerated Foods and Ault Foods.

Quality Assurance

• Produced Annual Product Reviews according to schedule for pharmaceutical products by compiling and reviewing data for complaints, deviations, changes, validation, packaging, stability and laboratory tests.
• Performed statistical analysis using Statistica software program.
• Identified trends and made recommendations on course of action.
• Maintained databases for completed Product Reviews and outstanding notifications.
• Revised Product Quality Review program to incorporate new initiatives and Global Corporate requirements.

Regulatory

• Ensured regulatory compliance of processes with Good Manufacturing Practice and current Canadian, U.S., Rest of World and Global Corporate regulations.

Auditing

• Conducted internal compliance audits in Quality Assurance and Manufacturing areas to ensure compliance with corporate quality standards.
• Provided support during local and regulatory audits.

GMP Training

• Performed employee training on standard operating procedures (SOPs).

Technical Writing

• Created and revised SOPs, Training Modules and Performance Assessments.

Validation

• Assisted microbiology lab in performing water system validation for new building.

Lab Services

• Performed various microbiological tests on finished products, raw materials, media, the environment, water and compressed gases.
• Documented results using LIMS and SAP.
• Reviewed tests conducted by analysts and ensured specifications were met.
• Conducted laboratory audits and prepared reports.
• Certified Trainer.
• Actively participated in investigations.
• Trained and coached analysts on laboratory procedures.
• Trended data and produced reports.
• Won a Process Improvement Project of the Month award for the revision of the Compressed Dry Air monitoring program.
• Worked as part of a cross-functional team to bring microbiology autoclave and other laboratory equipment into compliance with 21 CFR Part 11 and internal policies.
• Coordinated and executed autoclave software upgrade and re-qualification.
• Worked as part of team to redesign microbiology laboratory.

Education

• Honours Bachelor of Science in Applied Microbiology, University of Guelph, Guelph, Ontario

Continuing Education, Career Development

• Conducting Annual Product Reviews – PSG 2007
• Auditing and Regulatory Inspections – GSK 2004
• GMPs for Lab Personnel – GSK 2003
• Computer Validation – PSG 2001
• Microbiological Auditing – PSG 1999
• Internal Computer Training in Statistics, SAP, Word, Excel and PowerPoint