Sharon Aponte
Pembroke Pines,FL
Summary
Quality Assurance professional with over 19 years of experience in the Pharmaceutical and Medical Device industries, specializing in quality systems, regulatory compliance, stability testing, and enterprise software management. Adept at leading cross-functional teams, conducting audits and mentoring staff on quality standards and regulatory requirements. Known for meticulous attention to detail, strong communication skills, problem-solving ability, and driving continuous improvement.
Overview
22
22
years of professional experience
Work History
Quality Analyst II
Teva Pharmaceuticals
06.2023 - Current
- Lead the development, execution, and approval of stability protocols, ensuring compliance with cGMP, USP, and FDA regulations (21 CFR Parts 210 & 211).
- Collaborate with QC, R&D, and Regulatory Affairs teams to define product testing parameters, stability study requirements, and maintain consistency across protocols.
- Manage stability sample logistics, including inventory scheduling, sample pulls, receipt documentation, and maintaining sample integrity.
- Monitor and report on stability trend data to assess product shelf-life and support regulatory submissions, including FDA filings and Annual Product Review (APR) reports.
- Compile detailed stability reports and contribute to product lifecycle documentation to support regulatory approvals.
- Provide data-driven insights for stability-related investigations and support CAPA implementation.
- Assist cross-functional teams with stability data and trend analysis to enhance regulatory compliance and site inspection readiness.
Quality Specialist System
Thermo Fisher Scientific
11.2021 - 07.2023
- Designed product labels and conducted AQL inspections on incoming components and finished products to ensure compliance with specifications and quality standards.
- Reviewed, approved, and issued production batch records and Design Change Orders (DCOs), ensuring strict adherence to GMP, SOP, and regulatory guidelines.
- Led quality investigations by identifying root causes and driving corrective and preventive actions (CAPA) to resolve non-conformances effectively.
- Developed and delivered training sessions on quality systems and regulatory compliance; served as a Subject Matter Expert (SME) to mentor team members.
- Managed review and approval of product specifications and change control processes, ensuring all design and production changes complied with regulatory and internal standards.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Inspected items and compared against standards to meet regulatory requirements.
- Performed tests and inspections to conform to established standards.
- Developed and implemented procedures to meet product quality standards.
- Reported problems and concerns to management.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Reviewed production processes and identified potential quality issues.
- Recorded and organized test data for report generation and analysis.
Quality Specialist II
Teva Pharmaceuticals
07.2012 - 11.2021
- Ensured products and manufacturing processes met FDA regulations (21 CFR Parts 210 & 211), cGMP, and ISO standards through thorough inspections.
- Managed deviations and corrective actions (CAPAs) by investigating issues and working with teams to make sure fixes were effective.
- Inspect raw materials and environmental conditions to maintain product quality in GMP areas.
- Prepared for internal and external audits by keeping documentation complete and compliant with GMP standards.
- Collaborated with R&D, QC, Regulatory Affairs, and manufacturing teams to maintain high-quality products.
- Supported daily manufacturing by assisting production activities, ensuring safety and cleanliness, troubleshooting quality problems, and making sure equipment and materials were ready and approved for use.
Quality Inspector I
PLD Developments
08.2010 - 04.2012
- Worked with specific production team members to rectify production issues and maintain high-quality final products.
- Collected samples during production and tested randomly to determine in-process product quality.
- Identified defects during cyclical checks.
- Identified and helped resolve non-conforming product issues.
- Monitored production operations for compliance with specifications and promptly reported defects.
- Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
- Communicated with production team members about quality issues.
- Inspected incoming and outgoing materials for accuracy and quality.
- Participated in team meetings to discuss progress and results, providing ideas and suggestions for improvement.
- Collaborated with production staff to establish and meet quality standards
QA Receiving Inspector
Boston Scientific
03.2010 - 08.2010
QA Associate I
Azopharma Contract Pharmaceutical Services
07.2007 - 01.2010
QA Inspector I
Swiss Caps USA
11.2006 - 06.2007
QA Auditor
Cordis LLC Johnson & Johnson
01.2004 - 08.2006
Education
Associate of Science (AS) - Business Administration
Atlantis University
Miami, FL01.2023
Bachelor of Science (BS) - Business Administration, Major in Systems
Atlantis University
Miami, FL01.2026
Skills
- Regulatory & Quality Systems Expertise: In-depth knowledge of GMP, FDA 21 CFR Parts 210/211, ISO 13485, CAPA, deviation management, and regulatory submissions Experienced in conducting internal and external audits and ensuring compliance with quality assurance protocols
- Stability & Testing Proficiency: Skilled in developing and managing stability protocols, trend data analysis, stability reporting, product lifecycle documentation, and sampling techniques including random sampling
- Enterprise Software & Tools: Advanced expertise in LIMS (Laboratory Information Management Systems) and TrackWise for quality event management Proficient with SAP (production planning and inventory), JD Edwards (manufacturing modules), EMS (Environmental Monitoring Systems), Glorva DMS (document management), and Microsoft Office Suite
- Communication & Customer Focus: Strong active listening and communication skills with the ability to simplify technical information for diverse audiences Effective at managing customer expectations and maintaining positive relationships under pressure
- Leadership & Training: Proven SME trainer and mentor with experience leading cross-functional teams, driving process improvements, and fostering a culture of innovation and quality excellence
- Organizational Skills: Highly detail-oriented with excellent multitasking, prioritization, and time management capabilities, ensuring deadlines are met without compromising accuracy or compliance
Timeline
Quality Analyst II
Teva Pharmaceuticals
06.2023 - Current
Quality Specialist System
Thermo Fisher Scientific
11.2021 - 07.2023
Quality Specialist II
Teva Pharmaceuticals
07.2012 - 11.2021
Quality Inspector I
PLD Developments
08.2010 - 04.2012
QA Receiving Inspector
Boston Scientific
03.2010 - 08.2010
QA Associate I
Azopharma Contract Pharmaceutical Services
07.2007 - 01.2010
QA Inspector I
Swiss Caps USA
11.2006 - 06.2007
QA Auditor
Cordis LLC Johnson & Johnson
01.2004 - 08.2006
Associate of Science (AS) - Business Administration
Atlantis University
Bachelor of Science (BS) - Business Administration, Major in Systems
Atlantis University