Roberta MacQueen
New Dominion,PEI
Summary
Detail-oriented individual with exceptional communication and project management skills. Successfully implemented innovative quality assurance processes, resulting in increased productivity and operational efficiency. Proven ability to quickly adapt and handle multiple tasks effectively and efficiently in fast-paced environments. Recognized for taking proactive approach to identifying and addressing issues, with focus on optimizing processes and supporting team objectives.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Consultant
RK Consulting
01.2021 - Current
- Evaluated client needs and expectations, establishing clear goals for each consulting engagement.
- Liaised with customers, management, and sales team to better understand customer needs and recommend appropriate solutions.
- Collaborated with cross-functional teams to successfully deliver comprehensive solutions for clients.
- Managed client relationships through regular check-ins and updates on project progress.
- Identified areas of improvement for clients'' operations, implementing targeted solutions to increase productivity.
- Streamlined internal processes to enhance team efficiency and improve overall project outcomes.
- Designed tailored training programs for employees at various levels within the organization, boosting overall skillsets.
- Facilitated workshops and training sessions for client staff, enhancing their skills and knowledge in key areas.
- Improved organizational efficiency, overhauling outdated operational procedures with innovative, tech-driven solutions.
- Established best practices for project management within client organizations, leading to more predictable and successful outcomes.
Head of Quality
MicroSintesis
11.2021 - 07.2022
- Developed and maintained comprehensive documentation of quality processes, ensuring consistent adherence to established procedures across all departments and teams.
- Managed the resolution of customer complaints, leading investigations to determine cause and implementing corrective actions to prevent recurrence.
- Served as a primary point of contact for regulatory agencies during inspections and audits, demonstrating the company''s commitment to compliance and continuous improvement.
- Oversaw the maintenance of ISO 9001 certification by ensuring continuous process improvements within the organization.
- Ensured compliance with industry regulations by staying up-to-date on changing standards and providing guidance across multiple departments.
- Enhanced employee engagement in quality initiatives by recognizing individual contributions and promoting a culture of accountability.
- Championed a culture of continuous improvement by fostering open communication channels between employees at all levels within the organization.
- Developed comprehensive training programs for new hires, resulting in increased efficiency and knowledge among staff members.
- Managed and archived quality documentation and participated in internal and external quality audits.
- Updated quality control standards, methods, and procedures to meet compliance requirements.
- Determined quality department standards, practices, and procedures.
- Implemented new quality assurance and customer service standards.
- Specified quality requirements of raw materials with suppliers.
Quality Specialist
BioVectra
03.2012 - 12.2020
- Assisted in the implementation of a continuous improvement culture, contributing to company-wide improvements in productivity and waste reduction.
- Developed comprehensive quality control documentation, standardizing procedures across all departments and promoting consistency.
- Improved product quality by implementing rigorous testing protocols and identifying areas for improvement.
- Collaborated with cross-functional teams to identify process improvements, resulting in increased production efficiency and cost savings.
- Conducted detailed root cause analyses following any non-conformance events, leading to swift identification and mitigation of potential risks.
- Implemented a robust quality management system, leading to more consistent product output and reduced defects.
- Reviewed production processes and identified potential quality issues.
- Developed and implemented procedures to meet product quality standards.
Laboratory Technologist
Neurodyn
05.2008 - 03.2012
- Performed high complexity testing by preparing specimens for analysis and maintaining assay quality.
- Developed strong working relationships with colleagues from different departments, fostering collaboration towards shared goals.
- Consistently maintained a high level of accuracy in test results, ensuring confidence in the laboratory''s findings among healthcare providers.
- Trained new Laboratory Technologists on best practices and standard operating procedures, ensuring consistent team performance.
- Continuously improved laboratory processes through regular review and implementation of updated industry standards.
- Analyzed clinical samples on LC/MS-MS, resolving unusual data trends and handling chromatography and instrument alarms as appropriate.
- Enhanced laboratory efficiency by implementing effective inventory management and organization systems.
- Contributed to research projects by providing accurate data analysis, aiding in the discovery of crucial findings.
Education
Holland College
CharlottetownSkills
- Project leadership and Management
- Quality Assurance
- Policy Development
- Continuous Improvement
- Workflow and Process Efficiencies
- System Management
- Training and Development
- Change management
- Proposal development
Accomplishments
Successfully planned and implemented full electronic management system to take Biovectra from paper to online. Included the completion of all change management, validation and training aspects while meeting strict FDA and Health Canada regulatory requirements.
Implemented and authored a full Human Resource manual and policies for a GMP compliant Quality Management System for a start up company
Designed and created an online onboarding workflow for new employees, ensuring job specific requirements and training were delivered on arrival.
Proposed, sourced, planned and implemented a software program to redesign a manually managed stability program for a Quality Control laboratory. Decreased missed testing by 90%, and lag time in result reporting by 92% while eliminating the need for additional headcount.
Certification
- CPR/AED Certification
- ServSafe Food Handler's Certification
Timeline
Head of Quality
MicroSintesis
11.2021 - 07.2022
Consultant
RK Consulting
01.2021 - Current
Quality Specialist
BioVectra
03.2012 - 12.2020
Laboratory Technologist
Neurodyn
05.2008 - 03.2012
- CPR/AED Certification
- ServSafe Food Handler's Certification
Holland College
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