Danielle Silva Gonzales
Quality Systems Manager
West Richland,WA
Summary
Proven leader in quality management and operational excellence, notably at Grifols Plasma. Excelled in enhancing product quality and efficiency, achieving significant process improvements and compliance rates. Skilled in Quality Management Systems and team training, adept at fostering teamwork and collaboration. Demonstrated ability to drive results through innovative solutions and a strong work ethic, ensuring high levels of customer satisfaction and regulatory compliance.
Overview
8
8
years of professional experience
Work History
Quality Systems Manager
Grifols Plasma
09.2022 - Current
- Championed root cause analyses to accurately pinpoint areas of improvement within the organization''s processes and procedures.
- Advised management of quality audit non-compliance issues to facilitate improved audit compliance rates.
- Maintained quality system documentation and updated specific documents to reflect new audit or test results.
- Streamlined production processes for increased efficiency and reduced manufacturing defects.
- Evaluated suitability of business and technical processes and procedures and recommended improvements to comply with updated operations guidelines.
- Drove cost savings by identifying inefficiencies in processes, proposing and implementing solutions for increased profitability without sacrificing product quality.
- Tracked corrective action reports and confirmed closure of corrective action requests to demonstrate adherence to quality standards.
- Worked with users to maintain accurate quality records and supporting materials to document quality-related activities.
- Monitored active and inactive department rosters and updated database to reflect employee additions and deletions.
- Led cross-functional teams in designing and executing process improvement initiatives for better product performance.
- Reduced error rates by conducting regular audits of operation performance.
- Assured regulatory compliance with applicable industry standards by staying abreast of updates or changes in requirements, adjusting organizational policies accordingly when necessary.
- Enhanced product quality by developing and implementing robust quality management systems.
- Improved communication channels between departments through routine meetings focused on addressing challenges related to maintaining high levels of product quality.
- Implemented comprehensive training programs for staff, ensuring consistent understanding and application of established processes across all departments.
- Managed and archived quality documentation and participated in internal and external quality audits.
- Evaluated quality problems and performed assessments to identify and resolve issues.
- Mentored and encouraged employees to strive for excellence while fostering professional growth.
- Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
- Determined quality department standards, practices, and procedures.
- Applied coaching techniques and tools to support managers and team members in improving performance.
- Reported production malfunctions to managers and production supervisors.
- Implemented new quality assurance and customer service standards.
- Monitored staff organization and suggested improvements to daily functionality.
Center Operations Manager
Grifols Plasma
03.2021 - 09.2022
- Reduced operational costs by identifying areas for improvement and implementing cost-saving measures.
- Managed a team of employees, ensuring proper training and development for optimal performance in their roles.
- Coordinated staffing schedules, balancing both employee needs and business demands to maintain optimal coverage during peak hours.
- Enhanced center efficiency by implementing streamlined processes and procedures.
- Led the successful implementation of new technologies to improve overall operations and customer experience at the center.
- Provided regular feedback on employee performance, offering guidance and support for professional growth opportunities when needed.
- Resolved escalated conflicts between staff members or customers effectively while preserving positive working relationships.
- Created an inclusive work culture cultivating diversity fostering collaboration among staff members.
- Implemented effective inventory management systems to maintain appropriate stock levels while minimizing waste and overstock situations.
- Implemented targeted marketing campaigns that resulted in increased foot traffic into the facility.
- Increased customer satisfaction rates through consistent monitoring of service quality and addressing concerns promptly.
- Maintained a safe work environment by enforcing safety protocols, conducting regular inspections, and addressing potential hazards swiftly.
- Developed strong relationships with vendors to negotiate contracts, resulting in reduced expenses for the center.
- Oversaw daily center activities, delegating tasks as necessary to ensure smooth workflow and meet deadlines.
- Collaborated with cross-functional teams to drive continuous improvement efforts throughout the organization.
- Participated in community outreach programs showcasing our commitment towards community engagement.
- Applied performance data to evaluate and improve operations, target current business conditions and forecast needs.
- Managed work and performance of more than 25 employees.
- Ensured compliance with company policies, industry regulations, and local laws within all aspects of center operations.
- Introduced new methods, practices, and systems to reduce turnaround time.
- Evaluated and enhanced training programs to strengthen operations.
- Processed payroll for over 25 employees
- Trained and guided team members to maintain high productivity and performance metrics.
- Interacted well with donors to build connections and nurture relationships.
- Handled problematic donors to assist lower-level employees and maintain excellent customer service.
- Assisted in recruiting, hiring and training of team members.
- Tracked employee attendance and punctuality, addressing repeat problems quickly to prevent long-term habits.
- Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
- Scheduled employees for shifts, taking into account donor traffic and employee strengths.
- Tracked trends and suggested enhancements to both challenge and refine company's plasma goal to reports.
Quality Assurance Associate
Grifols Plasma
11.2019 - 03.2021
- Supported audit preparation through research, analysis and presentation development.
- Assessed quality of finished products with careful inspections.
- Assisted with independent internal and external audits.
- Maintained Deviation records for compliance and analysis purposes.
- Maintained neat, tidy work environment in Plasma Center facility.
- Collaborated with managers to write procedures for both Quality and Operation departments.
- Provided valuable insights during root cause analysis sessions, leading to targeted improvements in manufacturing processes.
- Participated in cross-functional meetings to ensure alignment between quality assurance objectives and overall company goals, fostering a collaborative working environment.
- Assisted in the development of training materials, boosting employee understanding of quality standards and expectations.
- Collaborated with team members to develop robust test plans, ensuring comprehensive coverage of all critical features.
- Improved overall product consistency by developing standardized procedures for routine quality checks across multiple departments.
- Promoted a culture of attention to detail within the team by emphasizing the importance of precision in all aspects of work.
- Streamlined quality assurance processes, resulting in improved efficiency and reduced error rates.
- Mentored junior team members on best practices within the realm of quality assurance, cultivating a strong foundation for future success.
- Analyzed quality and performance data to support operational decision-making.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Fixed identified issues to increase productivity and boost workflows.
- Promoted adherence to quality standards by educating personnel on quality control.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Addressed non-conformance issues, pausing production to correct errors.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Updated inspection journals and daily summary logs with quality-related data.
- Reported problems and concerns to management.
- Reviewed production processes and identified potential quality issues.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Collected and analyzed data to measure effectiveness of quality control processes.
- Developed and implemented procedures to meet product quality standards.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
Plasma Center Technician
Biolife Plasma Services
11.2016 - 09.2017
- Performed precise plasma collection procedures, ensuring donor comfort and minimizing adverse reactions.
- Managed emergency situations effectively, responding quickly to address donor needs or concerns with care and professionalism.
- Enhanced donor safety by conducting thorough pre-donation screenings and health assessments.
- Contributed to continuous improvement efforts through participation in staff meetings, trainings, and workshops.
- Ensured accurate documentation for each donation, maintaining strict adherence to FDA guidelines and company protocols.
- Maintained high-quality standards by performing regular equipment maintenance checks and calibrations.
- Assisted in training new technicians, sharing best practices to ensure consistent quality across the team.
- Achieved compliance with OSHA regulations through rigorous attention to safety protocols both in sample handling and overall facility cleanliness.
- Promoted a positive atmosphere among donors and staff, fostering strong relationships that encouraged repeat donations.
- Ensured smooth operations by communicating regularly with management regarding any issues or improvements needed within the center.
- Increased donor satisfaction by providing exceptional customer service during the entire donation process.
- Ensured proper storage and handling of collected plasma samples, maintaining the integrity of the product to be used for life-saving treatments.
- Participated actively in ongoing professional development opportunities offered by employer, staying current on industry trends.
- Collected blood samples in accordance with laboratory protocols and regulations.
- Collected blood samples using vacutainer tubes, tourniquets, syringes, butterfly needles, and straight needles.
- Drew blood from veins by vacuum tube, syringe, or butterfly venipuncture methods.
- Performed venipunctures, and finger sticks to prepare donor for plasmapheresis procedure.
- Verified patients' identification for proper sample collection.
- Reduced wait times for donors by efficiently scheduling appointments according to center capacity constraints and individual preferences.
- Monitored vital signs continuously throughout the donation process, promptly addressing any fluctuations or concerns as they arose.
- Collaborated with team members to achieve a clean and organized work environment, promoting efficiency and reducing errors.
- Supported fellow technicians during busy periods or absences, demonstrating adaptability in various roles throughout the center.
- Participated in quality assurance and competency assessment initiatives.
- Followed established safety protocols and standards to minimize risk of infection and injury.
Education
High School Diploma -
Kennewick High School
Kennewick, WA 05.2001 -
Associate of Applied Science -
Columbia Basin College
Pasco, WA 05.2001 -
Skills
Quality Management Systems
Operational Excellence
GMP Knowledge
Corrective Actions
Preventive Actions
Root Cause Analysis
Continuous Process Improvement
Document Control
Quality Metrics
CAPA Management
Risk Mitigation
SAP
Performance Reports
Internal Quality Audits
Quality Risk Management Planning
Trackwise
Problem-solving abilities
Quality processes
Documentation Control
Customer Satisfaction
Statistical analysis skills
Team Training
Internal Auditing
Operational Improvements
Performance monitoring
Compliance Monitoring
Continuous Improvement
Regulatory Compliance
Teamwork and Collaboration
Customer Service
Problem-Solving
Time Management
Multitasking
Strong Work Ethic
Multitasking Abilities
Excellent Communication
Decision-Making
Defect Identification
Organizational Skills
Employee Supervision
Team building
Attention to Detail
Adaptability
Analytical Thinking
Relationship Building
Staff Supervision
Statistical Analysis
Timeline
Quality Systems Manager
Grifols Plasma
09.2022 - Current
Center Operations Manager
Grifols Plasma
03.2021 - 09.2022
Quality Assurance Associate
Grifols Plasma
11.2019 - 03.2021
Plasma Center Technician
Biolife Plasma Services
11.2016 - 09.2017
High School Diploma -
Kennewick High School
05.2001 -
Associate of Applied Science -
Columbia Basin College
05.2001 -