Erica Dumeng
Palm Bay,FL
Summary
Detail-oriented Quality Systems Associate with 1.5 years of experience supporting the development and maintenance of quality management systems (QMS) in regulated industries. Proficient in document control, SOP management, and compliance tracking. Skilled in conducting internal audits, facilitating corrective actions, and ensuring adherence to regulatory requirements. A proactive team player with strong analytical abilities and a commitment to continuous improvement.
Overview
14
14
years of professional experience
Work History
Quality Systems Associate
Grifols Biomat USA
02.2023 - Current
- Assists Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
- Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during donation.
- Creates, maintains, and audits training records and files to ensure compliance.
- Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
- Completes weekly review of equipment QC and maintenance records.
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
- Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.
- Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in timely fashion, and that staff performs according to all SOPs.
- Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports critical incidents and problematic trends to Center Manager.
- Collaborated with cross-functional teams to ensure alignment of quality processes with organizational goals and objectives, providing training and support as needed.
Training Coordinator
Grifols Biomat USA
09.2021 - 02.2023
- Maintained accurate records of employee participation in training events, tracking progress towards learning objectives.
- Coordinated with department leaders to identify training needs and develop targeted solutions.
- Collaborated with department managers to design customized training plans aligned with organizational goals.
- Scheduled and coordinated training sessions, including booking facilities and arranging catering.
- Created and maintained detailed training records and reports for management review.
- Developed engaging instructional materials, including presentations, handouts, and interactive activities.
- Worked with central management to identify, plan, align, and address training needs.
- Monitored training reports within learning management system for respective roles to promote initial and annual training completion.
- Streamlined onboarding processes for new hires, resulting in reduced time to full productivity.
- Trained and mentored over 15 new personnel hired to fulfill various roles.
Sales Associate
Kohl's
03.2021 - 11.2021
- Organized racks and shelves to maintain store visual appeal, engage customers, and promote specific merchandise.
- Handled cash transactions efficiently while adhering to company cash handling policies, ensuring accuracy in all financial exchanges.
- Built relationships with customers to encourage repeat business.
- Managed returns, exchanges and refunds in accordance with store policy.
- Maintained calm demeanor and professionally managed issues in busy, high-stress situations.
- Helped customers locate products and checked store system for merchandise at other sites.
- Provided positive first impressions to welcome existing, new, and potential customers.
- Rotated stock and restocked shelves to maintain product availability and store appearance.
Donor Center Technician
Grifols Biomat USA
02.2016 - 09.2021
- Increased donor satisfaction with thorough pre-donation screenings, ensuring eligibility and minimizing risks.
- Maintained accurate donor records through diligent data entry and documentation efforts.
- Ensured donor safety and comfort by closely monitoring vital signs during donation process.
- Enhanced donor experience by providing exceptional customer service and maintaining clean, organized workspace.
- Responded promptly to donor inquiries and concerns, demonstrating empathy and understanding to resolve any issues that arose.
- Reduced wait times for donors by efficiently managing appointment scheduling and walk-in traffic.
- Assisted in achieving center goals by successfully processing high volume of donors daily.
Biologics Assistant
OneBlood
08.2010 - 02.2015
- Manufactures, stores and distributed blood and blood products.
- Operates, maintains and performs quality control checks on equipment.
- Ensured suitability and accurate labeling of products for release and distribution.
- Performs quarantine and disposition of unacceptable products and samples.
- Contributed to positive work environment with strong interpersonal skills and proactive teamwork attitude.
Education
Bachelor of Applied Science - Organizational Management
Eastern Florida State College
Cocoa, FLSkills
- Regulatory Compliance
- Document Control and SOP Management
- Risk Management
- Internal Audits and Inspections
- Root Cause Analysis and CAPA Implementation
- Data Analysis and Reporting
- Team Leadership and Collaboration
- MS Office
- Attention to Detail
- Training and Development
Timeline
Quality Systems Associate
Grifols Biomat USA
02.2023 - Current
Training Coordinator
Grifols Biomat USA
09.2021 - 02.2023
Sales Associate
Kohl's
03.2021 - 11.2021
Donor Center Technician
Grifols Biomat USA
02.2016 - 09.2021
Biologics Assistant
OneBlood
08.2010 - 02.2015
Bachelor of Applied Science - Organizational Management
Eastern Florida State College