Christelle Gardinor
Stewartsville,NJ
Summary
Looking for the next role to obtain a leadership position which provides the opportunity to play a longevity direct position in the growth and success of a high-performing organization. The objective is to leverage experience and apply creativity, drive, and determination to consistently achieve success and to take on new and challenging assignments in support of continued professional development.
Overview
17
17
years of professional experience
1
1
Certification
Work History
QA Tissue Services Sr. Manager
AbbVie
05.2019 - Current
- Responsible for directing and managing day to day operations of Tissue Services responsible for record review for Finished Goods processing
- Ensure effective operations, procedures and files are compliant with FDA, AATB, Korea MFDS, ISO13485/19011 regulations for release
- Act as a liaison between tissue procurement agencies and Abbvie
- Strengthening partnership with Manufacturing, Supplier Quality, Change Management and external partners ensuring alignment
- CAPA/Nonconformance Investigation within Quality organization and Manufacturing
- Quality Management System Review Metrics
- Generated Standard Operating Procedures
QA Tissue Services Manager
AbbVie
10.2018 - 05.2019
- Responsible for directing and managing the operations of LifeCell Tissue Services
- Ensure effective operations and donor files are compliant with all state, Federal and AATB regulations
- Act as a liaison between tissue procurement agencies and Lifecell
- CAPA/Nonconformance Investigation within Quality organization and Manufacturing
- Quality Management System Review Metrics
- Ensure effective operations, procedures and donor files are compliant with FDA,AATB, Korea MFDS, ISO13485/19011 regulations for release
- Generated Standard Operating Procedures
QA/QC Quality Product Release and Final Inspection Manager
AbbVie
03.2016 - 03.2018
- Managed Day to day activities for Final Inspection and Product Batch Release
- Reviewed ECO’s to determine/assess impact to the departments
- Acted as key liaison between Product Release, Incoming and Final Inspection and other cross-functional support groups
- Identified process gaps or inefficiencies in current processes
- Act as mentor and coach to team members, ensuring development plans are in place
- Analyze internal processes to recommend and implement procedural or policy changes to improve operations
- Develop a more efficient process for cross-functional training which resulted in faster onboarding and positive impact to department and individual goals
- CAPA/Nonconformance Investigation within Quality organization and manufacturing
- Ensure effective operations, procedures and donor files are compliant with FDA, AATB, Korea MFDS, ISO13485/19011 regulations for release
QA/QC Quality Product Release Supervisor
AbbVie
03.2014 - 03.2016
- Ensure effective operations releases are compliant with all state, Federal and AATB regulations
- Managed day to day activities for prioritizing based on the business demands
- Develop and track productivity and cycle time metrics
- Investigate NCR’s as deemed necessary Identify training gaps within the department and propose plans to close the gaps and create a backup plan
QA/QC Quality Product Release Analyst
AbbVie
12.2011 - 03.2014
- Develop and maintain metrics/cycle time reports to be communicated to Leadership including, but not limited to, identifying backlogs, aging reports, NCR and Correction, and defect rates
- Compiles and performs trending of issues encountered at batch record review to identify any drift in performance or potential compliance issues
- Assess impact of ECO’s to Batch Release and Inspection documentation and processes
- Confirm research consent for lots designated for marketing, research, or validation purposes
- Make the final determination regarding the suitability of LifeCell products for release to Finished Goods and/or other dispositions, including rejection
QA/QC Quality Release Specialist
AbbVie
08.2010 - 12.2011
- Conducted final review of processing batch records for compliance with all current specified requirements and procedures to determine suitability of LifeCell product for final disposition based on FDA, ISO, AATB regulations
- Initiated Non-Conformances when applicable if determined the product does not comply with current written procedures/specifications
- Initiated reworks for manufacturing and generate Certificate of Conformances as deemed necessary
- Worked closely with Manufacturing and Quality to resolve any discrepancies uncovered during the batch record review
- Completed the Final Disposition Tissue Disqualification Reports for rejected incoming tissue, ensuring the tissue was discarded appropriately and all required documentation is completed for traceability purposes
Quality Release Coordinator
AbbVie
10.2007 - 08.2010
- Reported final product releases on a daily basis to upper management
- Responsible for prioritizing lot batch folders for review based on customer service needs
- Acceptance review and transfer of released product to Finished Goods
- Assisted in various projects within Quality Product Release as requested by the department Manager
Education
MBA - Business Administration And Management
Excelsior University
Albany, NY06.2024
Bachelor of Arts -
Excelsior University
Albany, NY03.2022
Skills
- >15 years of Quality/GMP and GXP Experience
- Quality / Compliance Minded
- Team Leadership
- Detailed and Organized
- Drives Accountability and Effectiveness
- Positive Change Agent
- Time Management Skills
- Shared Values/ Active Listening
- Proactive / Takes Initiative
- Self-Directed
- Cross-Functional Collaboration and Teamwork
- Results Driven
- Change Management
- Analytical Skills
- Critical Thinking
- Proficient in Microsoft Office Suite (PowerPoint, Outlook, Word, Excel, Access, Visio)
- SAP/ Track Wise / Compliance Wire/ Veeva Vault
- Relationship building
- Staff training and development
- Decision-making
- Verbal and written communication
- Complex Problem-solving
- Staff management
- Task delegation
- Goal setting
- Documentation and reporting
- Strategic planning
- Operations management
- Project management
- Project planning
- Customer relationship management (CRM)
- Performance management
- Staff development
- Shift scheduling
- Policy implementation
- Conflict resolution
- Key performance indicators
- Expectation setting
- Clear communication
- Coaching and mentoring
- Policy and procedure development
- Data analysis
- Change management
- Regulatory compliance
- Cross-functional team management
- Teamwork and collaboration
- Effective communication
- Attention to detail
- Multitasking
- Problem-solving
Certification
- AATB /CTBS (Certified Tissue Banking Specialist)
- Lean Six Sigma Certified
- Green Belt Certified
- ISO13485 Certified
- Certified NCR/CAPA Investigator
Accomplishments
- 2019 Branchburg Employee of the Year
- 2019 CEO Bold Award
- Implemented RFID tracking system for donor file records while providing new technology to the site.
- Implemented an Online Indexing system for reduction of paper.
- Developed and Implemented a Portal for document and cycle time tracking at all levels of review and process for the Human Tissue Product Line.
- Developed an automated system for record identification.
- Streamlined the Frozen Tissue Disqualification/Discard Process resulting in a40% reduction in TAT.
- Standardization of RTU Quality Release SOP which identified and resolved any compliance gaps and alignment with Manufacturing Procedures
- Donor and Patient Story Recognition Days
Timeline
QA Tissue Services Sr. Manager
AbbVie
05.2019 - Current
QA Tissue Services Manager
AbbVie
10.2018 - 05.2019
QA/QC Quality Product Release and Final Inspection Manager
AbbVie
03.2016 - 03.2018
QA/QC Quality Product Release Supervisor
AbbVie
03.2014 - 03.2016
QA/QC Quality Product Release Analyst
AbbVie
12.2011 - 03.2014
QA/QC Quality Release Specialist
AbbVie
08.2010 - 12.2011
Quality Release Coordinator
AbbVie
10.2007 - 08.2010
- AATB /CTBS (Certified Tissue Banking Specialist)
- Lean Six Sigma Certified
- Green Belt Certified
- ISO13485 Certified
- Certified NCR/CAPA Investigator
MBA - Business Administration And Management
Excelsior University
Bachelor of Arts -
Excelsior University
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