Competent Quality Assurance Specialist with 7 years of experience in oversight of quality excellence. Proven record of quality leadership in all facets of production, team performance and fulfillment or delivery. Strategic in planning, implementing and improving processes and standards which generate opportunities for sustainable company growth.
Overview
7
7
years of professional experience
Work History
Sr. Assoc, Quality Control
West Pharmaceutical Services Inc
12.2023 - Current
Maintained compliance with applicable regulatory standards such as ISO 9000, 9001, 9004, 19011, 2000.
Assisted in training other staff members on proper use of test equipment, tools, and systems used in Quality Control operations.
Conducted periodic audits of the Quality Control department procedures and practices.
Checked outgoing orders for accuracy against customer specifications.
Developed reports summarizing the results of the inspection activities.
Resolved customer complaints related to product quality and documentation discrepancies.
Tracked progress on corrective actions taken following customer complaints or internal audits.
Ensured that corrective action was taken when necessary for non-conformances identified during inspections.
Investigated root causes of defective parts or assemblies and implemented appropriate corrective actions.
Developed and maintained quality assurance protocols, processes and procedures.
Performed root cause analysis of defects identified during testing cycles.
QUALITY TECH
WEST PHARMACEUTICALS
05.2018 - 12.2023
Responsibilities including visual inspection of product for defects, measuring spec verification of product, weigh-up entry and packing, Ash, UV-01 and IR testing, mold line releases, batch record review and release, and NCR reporting and bracketing.
FINISHER
WEST PHARMACEUTICALS
03.2017 - 05.2018
Responsibilities including proper PPE usage, proper completion of documents, Weigh-up entry, packing, rinsing, autoclave, baking, and silicone processes.
Education
Technology development and Management -
St. Petersburg College
05-2025
Skills
Quality leadership experience
Experience with HANA and PE1 SAP production systems
Experience in disposing of non-conforming products placed on hold by quality members
Work experience in laboratory settings where product is tested, and testing is used as release criteria
Dispositions and creates OOS reports for lab, dimensional, and visual failures during production
Generation and understanding of risk assessment processes and procedures
Experience in performing OOS and deviation investigations including root cause and corrective actions needed
Experience with unplanned and planned deviation procedures
Experience in performing data integrity and production floor audits
Experience in handling and verifying scrap of rejected products
Understanding and management of foreign item action plan and intermix reports
Experience working with customer complaints and customer audits
Understanding and knowledge of creation of reference diagrams for product specifications
Experience reviewing and creating SOIs, work instructions and training references
Certified trainer
Knowledge of computer networking including switching and routing
Experience working with programming languages such as Python, JavaScript, HTML, and CSS
Knowledge of bracketing and traceback procedures and systems