Lisa Bass
Middlesex,NC
Summary
Accomplished Quality Assurance Specialist with a proven track record at in the pharmaceutical industry enhancing product quality through meticulous root-cause analysis and quality process improvements. Skilled in data analysis and fostering team collaboration, I significantly contribute to maintaining regulatory compliance and driving continuous improvement initiatives. Expertise in FDA regulations and mentoring underscores my commitment to excellence and operational efficiency.
Overview
14
14
years of professional experience
Work History
Quality Assurance Specialist
DSM Pharmaceuticals
04.2012 - 04.2014
- Conducted a quality release of components and raw materials for use in manufacturing.
- Participated in regular meetings with cross-functional teams to discuss progress updates, communicate concerns or challenges, and ensure alignment of project.
- Maintained comprehensive knowledge of relevant industry regulations and standards, ensuring compliance throughout the QA process.
- Supported company in maintaining work environment focused on quality, communication, collaboration, integration, and teamwork.
QMS Consultant/Documentation Specialist
GlaxoSmithKline Pharmaceuticals
06.2006 - 06.2010
- Audited activities of workers on production lines and shipping and receiving.
- Compared quantity, quality and labeling of finished product to check accuracy and completeness.
- Enhanced product quality by conducting thorough audits and identifying areas for improvement.
- Gathered and reviewed current data to determine areas in need of improvement.
- Reviewed work instructions and production strategies to verify compliance with established standards.
- Inspected work areas regularly to identify safety practices, quality control procedures and worker actions in need of improvement.
- Facilitated implementation of the Quality Management System.
- Supported regulatory inspections by providing accurate documentation of audit findings and implemented corrective actions when necessary.
- Authored and modified standard operating procedures to facilitate quality and production activities.
- Served as quality documentation system administrator.
QA Training Specialist
GlaxoSmithKline Pharmaceuticals
05.2003 - 06.2006
- Evaluated training effectiveness using feedback surveys and assessments, making continuous improvements as needed.
- Enhanced employee performance by developing and implementing comprehensive training materials.
- Developed training modules and computer tutorials to support training implementation.
- Spearheaded updates to existing training materials to maintain relevance with industry best practices and evolving organizational needs.
- Trained and mentored new personnel
- Collected data on program effectiveness to develop modifications and improvements to curricula.
- Promoted a culture of continuous improvement by conducting regular follow-ups with trainees post-training.
- Developed customized training materials including presentations, job aids, and facilitator guides for effective knowledge transfer.
- Collaborated with department managers to identify skill gaps and develop targeted training interventions
- Conducted regular needs assessments to ensure alignment of training initiatives with organizational goals and objectives.
- Created and delivered cGMP training programs for operations.
Quality Control Analyst
GlaxoSmithKline Pharmaceuticals
01.2000 - 04.2003
- Conducted root cause analysis for recurring issues, developing long-term solutions to prevent recurrence.
- Provided training to new hires on quality control procedures, fostering a culture of excellence within the team.
- Analyzed finished products to verify effectiveness and compared results to regulatory requirements.
- Improved overall production efficiency by identifying and resolving quality control issues.
- Maintained a safe working environment, adhering to safety regulations and proper handling of hazardous materials.
- Conducted data review and followed standard practices to find solutions.
- Developed comprehensive documentation, maintaining accurate records of quality control results and actions taken.
- Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
- Ensured regulatory compliance by staying updated on industry standards and government regulations affecting product quality.
- Created and revised procedures, checklists and job aids to reduce errors.
- Developed and maintained quality assurance procedure documentation.
Education
Bachelor Of Science - Chemistry
Barton College
Wilson, NC05.1995
Smithfield Selma High School
Smithfield, NC06.1990
Skills
- Quality assurance
- Quality processes
- Data analysis
- Mentoring and training
- Issue resolution
- Quality assurance controls
- Root-cause analysis
- Deductive reasoning
- Collaboration and communication
- FDA regulations
- Group presentations
- Lean manufacturing
Timeline
Quality Assurance Specialist
DSM Pharmaceuticals
04.2012 - 04.2014
QMS Consultant/Documentation Specialist
GlaxoSmithKline Pharmaceuticals
06.2006 - 06.2010
QA Training Specialist
GlaxoSmithKline Pharmaceuticals
05.2003 - 06.2006
Quality Control Analyst
GlaxoSmithKline Pharmaceuticals
01.2000 - 04.2003
Bachelor Of Science - Chemistry
Barton College
Smithfield Selma High School
Similar Profiles
Jennie HedgepethJennie Hedgepeth
Sterile Inspector at Manpower (DSM Pharmaceuticals)Sterile Inspector at Manpower (DSM Pharmaceuticals)
ERIC CHRISTIANERIC CHRISTIAN
Aseptic Processing Manager, Senior Process Development Engineer at Ritedose PharmaceuticalsAseptic Processing Manager, Senior Process Development Engineer at Ritedose Pharmaceuticals
William WildWilliam Wild
Public Affairs Lead at Royal DSM/dsm-firmenichPublic Affairs Lead at Royal DSM/dsm-firmenich
Noemi NavarroNoemi Navarro
Helper at Cooper Electrical ConstructionHelper at Cooper Electrical Construction
Tariq McCargoTariq McCargo
Delivery Associate at AmazonDelivery Associate at Amazon