Carlos Vides-Reyes
Quality Operations
Boston,MA
Summary
Quality assurance professional with extensive experience in maintaining and improving product quality standards. Known for effective team collaboration and results-driven approach that adapts to changing needs. Possesses strong analytical skills and keen eye for detail, ensuring reliable and consistent quality outcomes. Thorough Quality Assurance Specialist with 17-year background in the Pharmaceutical Manufaturing. Excellent resource management and allocation skills.
Overview
17
17
years of professional experience
Certification
ASQ CQA - Certified Quality Auditor
ASQ CQIA - Certified Quality Improvement Associte
Affiliations
- American Society of Quality
Skills
- Data Integrity
- Project Management
- Trouble Shooting
- cGMP Investigations
- Column Chromatography
- Aseptic Manufacturing
- Continuous Improvement
Work History
Sr. QA Specialist - Operational Quality
Vertex Pharmaceuticals
Boston, MA
10.2022 - Current
- Conduct routine inspections to ensure compliance with quality standards and specifications.
- Engage in continuous learning of industry standards and best practices for quality management systems.
- Contribute to team meetings by sharing insights on potential process improvements for efficiency gains.
- Analyze performance metrics to identify trends and opportunities for improvement, driving continuous optimization of QA processes.
- Ensure stakeholder satisfaction by maintaining open lines of communication regarding project status updates and quality concerns.
- Contribute valuable insights during design reviews, helping guide product development towards improved user experience without sacrificing quality.
- Streamlined the QA process, leading to increased efficiency and faster release cycles.
- Review executed process documentation and technical documentation for accuracy and completeness, enhancing overall product understanding among team members.
- Established strong working relationships with development teams, fostering a collaborative environment that facilitated rapid identification and resolution of quality issues and QA MES SME for the VMC
- Assist in developing and implementing quality assurance procedures to enhance product reliability.
- Collaborate with team members to identify and resolve quality issues during the testing phase.
- Conduct regular floor walk-throughs to ensure adherence to industry standards and internal policies, maintaining a high level of compliance throughout the organization.
- Own and lead Continuous Improvement efforts within the QA group as well as with external partners.
- Serve as main QA point of contact for incoming clinical product campaign to the site.
Sr. Manufacturing Technician / Sr. QA Specialist
Oxford Biomedica Solutions (formerly Homology Medi
Bedford, MA
01.2021 - 10.2022
- Oversaw daily operations of manufacturing processes to ensure quality and efficiency.
- Led troubleshooting efforts for equipment malfunctions, minimizing downtime and maintaining productivity.
- Implemented process improvements that enhanced workflow and reduced waste in production lines.
- Collaborated with engineering teams to refine product designs based on manufacturability feedback.
- Supported new product launches through the development of custom tooling and fixtures for assembly lines.
- Implemented lean manufacturing principles to reduce waste, improve quality, and maximize resource utilization.
- Mentored junior team members and provided regular performance feedback, fostering a culture of continuous learning and professional growth.
Sr. QA Specialist/ QA Analyst – Data Integrity/CSV
Takeda Biologics
Lexington, MA
01.2019 - 02.2021
- Led quality assurance initiatives, enhancing product reliability and compliance with industry standards.
- Developed and implemented comprehensive testing protocols to ensure software functionality and performance.
- Mentored junior QA staff, improving team efficiency and knowledge sharing within the department.
- Collaborated with cross-functional teams to identify process improvements and resolve quality issues proactively.
- Provided QA oversight for DI deliverables in the Analytical Instrument Qualification and Computerized System Validation programs.
- Developed and trained DI SMEs in MFG on compliance and documenting of Data Integrity investigations.
- Reviewed and approved system level audit trail review reports for GXP operations and core automation systems/ admin operations.
- Generated and maintained a training program for operations groups on audit trail review procedures,
with a focus on DI and cGMP compliance.
QA Specialist II -QA Operations (Floor Support)
Shire Pharmaceuticals
Lexington, MA
02.2017 - 01.2019
- Served as primary point of contact for atypical events during the MFG process.
- Supported Quality Systems close out and product disposition activities.
- Processed SAP Master Data updates as a trained QA Master Data Steward.
- Collaborated with cross-functional teams to identify and resolve quality issues
- Trained junior staff on quality assessment techniques and best practices
- Led root cause analysis initiatives to minimize recurring quality failures
Sr MFG Technician/ MFG technician II - Bioreactor
Shire Pharmaceuticals
Lexington, MA
04.2015 - 02.2017
- Led critical, routine, and non-routine production floor operations in the Recovery suite.
- Increased department training compliance metric from 83% to 98% by leading training operations for Column Chromatography, UF/DF operations, and aseptic sampling.
- Supported Bioreactor operations for clinical and commercial products.
MFG Technician I/II - Protein Purification Ops
Shire Pharmaceuticals
Lexington, MA
03.2011 - 04.2015
- Packed, unpacked, qualified, and maintained GE AxiChrom chromatography columns for production.
- Operations team representative to the Manufacturing Compliance and 5S/LEAN Manufacturing.
- Certified Plant Spill Team and Medical Emergency Response Team member.
Timeline
Professional Certificate - SCHOOL OF ENGINEERING
UNIVERSITY OF ALABAMA: BIRMINGHAM
09.2024 - 11.2024
Sr. QA Specialist - Operational Quality
Vertex Pharmaceuticals
10.2022 - Current
Sr. Manufacturing Technician / Sr. QA Specialist
Oxford Biomedica Solutions (formerly Homology Medi
01.2021 - 10.2022
Sr. QA Specialist/ QA Analyst – Data Integrity/CSV
Takeda Biologics
01.2019 - 02.2021
QA Specialist II -QA Operations (Floor Support)
Shire Pharmaceuticals
02.2017 - 01.2019
Professional Certificate - Project Management
UMass: Lowell
02.2017 - 03.2017
Professional Certificate - Biotechnology
Worcester Polytechnic Institute
06.2015 - 06.2015
Sr MFG Technician/ MFG technician II - Bioreactor
Shire Pharmaceuticals
04.2015 - 02.2017
Professional Certificate - Biotechnology
WORCESTER POLYTECHNIC INSTITUTE
08.2013 - 08.2013
MFG Technician I/II - Protein Purification Ops
Shire Pharmaceuticals
03.2011 - 04.2015
GED -
Central Piedmont Community College
11.2007 - 01.2008
Education
GED -
Central Piedmont Community College
Charlotte, NC 11.2007 - 01.2008
Professional Certificate - Biotechnology
WORCESTER POLYTECHNIC INSTITUTE
Worcester, MA 08.2013 - 08.2013
Professional Certificate - Biotechnology
Worcester Polytechnic Institute
Worcester, MA 06.2015 - 06.2015
Professional Certificate - Project Management
UMass: Lowell
Lowell, MA 02.2017 - 03.2017
Professional Certificate - SCHOOL OF ENGINEERING
UNIVERSITY OF ALABAMA: BIRMINGHAM
Birmingham, AL 09.2024 - 11.2024