Robin Padula
Stoneham,MA
Summary
Experienced Quality Assurance Specialist with 15+ years in GMP, ISO, and FDA-regulated environments, recognized for ensuring compliance, streamlining processes, and supporting cross-functional teams. Recently retired from full-time work and now seeking part-time opportunities where I can contribute my skills, reliability, and collaborative approach. Known for attention to detail, strong organizational abilities, and a team-oriented mindset, I am open to quality-related or administrative roles where I can provide dependable support and help operations run smoothly.
Overview
6
6
years of professional experience
Work History
Quality Assurance Specialist 1
CAMBRIDGE ISOTOPES LABORATORIES, INC.
09.2024 - 01.2025
- Perform GMP batch record reviews and execute product release processes with precision and accuracy.
- Manage complaint and product return programs to ensure timely resolutions and regulatory compliance.
- Conduct room and line clearances while ensuring cleanliness and readiness for production.
- Support documentation activities, including writing and revising SOPs and protocols.
- Collaborate on quality improvement projects and contribute to ongoing administrative QA functions.
Quality Technician
CONVERGENT DENTAL
08.2023 - 08.2024
- Inspected incoming parts and final products to ensure compliance with internal and external specifications.
- Led calibration scheduling with external vendors, reducing turnaround time for critical instruments.
- Conducted root cause analysis on nonconformities and contributed to CAPA execution.
- Reviewed and approved Engineering Change Orders (ECOs) and Document Change Orders (DCOs).
- Supported FDA audit readiness and ISO recertification efforts through documentation and QMS alignment.
Senior Quality Specialist
COVARIS LLC
08.2018 - 06.2023
- Oversaw QA policy development, CAPA management, and QMS documentation updates.
- Facilitated FMEAs and updated periodic safety reports to enhance risk mitigation strategies.
- Validated effectiveness of corrective/preventive actions and maintained complaint databases.
- Implemented process improvements that streamlined calibration workflows and reduced rework.
- Applied Six Sigma and root cause methodologies to drive measurable quality improvements.
Education
Diploma -
Somerville High School
Skills
- Quality Assurance/Inspection
- Documentation & Recordkeeping
- Process Improvements & Workflow Efficiency
- Problem-Solving & Troubleshooting
- Contract Administration
- Audits and Compliance Support
- Lean Manufacturing
- Change Management
- General Admin and Office Management
- Microsoft Office (365/Access/Excel/PowerPoint/Teams)
- Detail-oriented
- Quality assurance
- Problem-solving skills
- Team collaboration
- Team leadership
Timeline
Quality Assurance Specialist 1
CAMBRIDGE ISOTOPES LABORATORIES, INC.
09.2024 - 01.2025
Quality Technician
CONVERGENT DENTAL
08.2023 - 08.2024
Senior Quality Specialist
COVARIS LLC
08.2018 - 06.2023
Diploma -
Somerville High School