Brenda Sparks

About Brenda Sparks

Loyal, productive professional with successful experience implementing new processes, procedures and overseeing regulatory compliance in post-market surveillance. Record of consistently executing and completing assigned tasks on schedule while complying with proper protocols/procedures, and producing high completion rate. Ability to think \"outside the box\" to streamline processes and to identify shortfalls. Possess strong interpersonal communications skills evidenced in ability to maintain positive relations and effectively work with multiple, diverse team members. Available for relocation. Specific areas of expertise include: Training/Mentoring FDA & ICH/GCP/GMP Regulations Internal & External Audits Team Collaborations Procedure Development / Implementation Strong Computer Skills Status Reports/Metrics Written / Oral Communications Site RelationsCAREER HIGHLIGHTS AND QUALIFICATIONS Spearheaded the development, implementation and training of new robust and streamlined processes which significantly reduced the time to compete tasks in the Post-Market Surveillance Department. Maintained detailed metrics of the Post-Market Surveillance department to ensure regulatory compliance. Managed the EUMDR implementation and certification team. Commended for above par performance throughout career in diverse environments. Achieved on time completion for all tasks assigned throughout career.

Experience

1. Quality Auditor

   BioLab Holdings

   Feb 2025 — Present · Mesa, AZ, US

   Led the development of the Supplier Control process to include supplier selection, evaluation, monitoring and termination of all company suppliers, including creating & maintaining the Approved Supplier List (ASL) and maintaining all QMS supplier files. • Developed the QMS supplier audit program and performed onsite, remote and desktop supplier audits within prescribed timeframes to include various regulations/standards (i.e, AATB, 21CFR1271, 21CFR820, ISO13485, ISO17025, ISO9001). • Conducted all critical supplier audits independently, within budget and project timelines including following up on all findings and observations.• Authored the Standard Operating Procedures (SOPs) and Work Instructions (WIs) to support and standardize Supplier Control processes, ensuring compliance and operational consistency.• Established a companywide standardized process for preparing for, managing and responding to FDA inspections to ensure compliance with applicable FDA regulations and to minimize risk of enforcement actions.• Organized and managed the Quality Hold/Quarantine area, overseeing inventory control and systematic arrangement of more than items to ensure accuracy, compliance, and operational efficiency. • Contributed to several other ad hoc Quality projects.

Education

• MiraCosta College

  Associate of Arts (A.A.), Psychology

• University of Phoenix

  Master's of Sciences, Psychology

  2008 — 2010

• UC San Diego

  Certificate, Clinical Trials Administration

  2007

• California State University San Marcos

  Bachelor of Arts (B.A.), Psychology

  1996 — 2000

Skills

• Strong Computer Skills
• Clinical Trials
• Written / Oral Communications
• Ich-Gcp
• Fda & Internal Audits
• Oncology
• Protocol
• Management Review
• Biotechnology
• Pharmaceutical Industry
• Sop
• Fda
• Clinical Development
• Protocol Development / Implementation
• Regulatory Affairs
• Fda & Ich/Gcp Regulations
• Quality Assurance
• Product Complaints
• Clinical Monitoring
• Clinical Data Management
• Regulatory Requirements
• Complaint Trending
• Medical Devices
• Clinical Research
• Capa
• Team Collaborations
• Complaint Investigations
• Study Status Reports
• Procedure Creation
• Software Documentation
• Edc
• Therapeutic Areas
• Ctms
• Training/Mentoring
• Work Instructions
• Iso 13485
• Application Monitoring
• Regulatory Submissions
• Post Market Surveillance
• Gcp