Lisa Rowland
Lyman,SC
Summary
Accomplished quality and regulatory expert with a solid track record at Alltrista Plastics LLC, adept at aligning quality systems across various locations. Expertise in CAPA and statistical process controls, facilitating continuous improvement and teamwork. Competent in managing FDA audits and enhancing supplier quality, ensuring adherence to compliance and operational excellence. Distinguished for leadership in quality management and process optimization, with a focus on clear communication and problem-solving.
Overview
37
37
years of professional experience
1
1
Certification
Work History
Sr Director of Quality and Regulatory Affairs
Alltrista Plastics LLC
12.2015 - Current
- Harmonized the quality management systems across 7 locations.
- Oversee implementation of company-wide IQS quality software management system.
- Implemented fully functional materials lab and expanded internal testing and metrology capabilities.
- Work closely with commercial, engineering, and manufacturing teams and direct the quality assurance and control of a rapidly expanding manufacturing portfolio of new programs.
- Introduced new quality tools including development of process FMEAs, CPK requirements, gauge R&R, statistical techniques manufacturing control plan development, validation packages, contingency planning, supplier quality and (NPI) new project introduction.
- Lead 2 FDA audits with 1 minor finding.
Director of Quality & Technical Services
Precision Valve North America, Inc.
11.2014 - 01.2016
- Drove initiatives focused on prompt resolution of quality and performance issues utilizing industry best practices.
- Planned, implemented and supervised work dedicated to continuous improvement of process and quality systems.
- This position was more about customer-facing engagement, troubleshooting issues, cost negations, and tool refurbishment.
- Supported operations, interfaced with customers, sales, marketing, supply chain, production planning, and customer service specialists to assure that customer needs were exceeded, and that the facility met the requirements of a highly effective quality management system.
- Precision Valve has 13 locations across the world.
several positions of increasing responsibility
Nutra Manufacturing (GNC)
06.1997 - 11.2014
- Positions included: Validation Tech, Validation Engineer, QC analytical/ micro lab Supervisor, Medicine/Gelatin Preparation Operations Manager, Supplier Quality Manager, Quality Manager, Director of Quality Management.
- At Nutra manufacturing, I had the benefit of working in numerous departments.
- I was in a bridge program where they identified upcoming leaders, and I would spend a year to two years in each job function to learn the interaction of the business.
- During that time, I had the privilege of working directly with the FDA for about nine months as they were evaluating Nutra (GNC) on establishing the guidelines for part 110 nutraceuticals.
- That 1 on 1 interaction taught me more about quality systems and the why behind how the standards were written, than in any part of my career.
- It has allowed me to elevate quality systems without throwing headcount to problems.
- Quality is a culture that everyone owns.
- Developed quality systems involving a thorough review of every function in the manufacturing plant and then incorporating process, systems, protocols, procedures, documentation, and manuals.
- Responsible for the annual Quality Department Budget and assisted with Capital Plan.
- Attended 3 / Lead 3 FDA audits.
- Performed problem analysis and developed corrective and prevention action.
- Developed OTJ training packets for all job titles including evaluation of performance.
- Trained leads/supervisors to be trainers to ensure consistency from shift to shift.
- Developed Site Master Plan and Validation and Cleaning Validation Master Plan.
- Managed Environmental Monitoring Program – air microbiological, air particulate, surface samples for walls, floors, and equipment.
- Evaluated and approved cleaners/ sanitizers for manufacturing and packaging departments.
- Managed a department of 118 employees as Operation Manager, and 82 employees as Director of Quality.
- Implemented new Supplier Qualification Program.
- Developed a tier supplier program, that included score cards, business reviews with suppliers, audits, change control agreements, supplier quality agreements, tooling PM agreements and approvals of validation activities for Nutra owned tooling.
Several Positions of Increasing Responsibility
Bausch & Lomb
Greer, SC
01.1989 - 06.1997
- Held positions as Fill/Prep Operator, Validation Technician, and Aseptic Supervisor.
- Executed IQ/OQ/PQ and PV on process equipment, sterilizers, water systems, and computer validations.
- Developed leadership skills by effectively communicating requirements in both written and verbal formats.
- Facilitated group discussions to convey essential information clearly and efficiently.
Education
Associates of Science - Business Management
Greenville Technical College
Greenville, SC05.1994
Skills
- AQL
- ANSI
- ASTM
- Asset Management
- Bulk Manufacturing
- 21 CFR part 110, 210 & 211, and 820
- Calibration
- CAPA
- Capital Budgeting
- Change Control
- CMM- Metrology
- Component Assembly
- Consumer Complaint Program
- Document Control
- Drug Site Master File
- Drug Master File- Manage filing /FDA
- Environmental Management Systems
- Equipment, Cleaning, Process, Computer Validation
- FAT and SAT
- FDA-820, 110, 210 & 211
- FDA filings and registration
- Gauge R&R
- HACCP
- HPLC, GC, and, ID testing equipment
- In-coming Inspection
- Injection Molding
- Internal/External Lead Auditing
- IQ/OQ/PQ
- ISO 13485 MD; 9001 QS; 14001 Env; 15378 PKG ISO
- Management Representative
- Kitting process and application
- Label claims and reviews
- Light weighting design testing
- Management Reviews
- Regulatory Guidelines (GLP and USP)
- Material Review Board
- Member of ASQ
- Mentoring Staff
- Metal Stamping
- Micro and chemistry labs
- Medical/pharma Filling
- OSHA 30-Hour General Industry
- Process Evaluation
- Process Improvements
- Program Implementation
- Product Introduction
- Quality Manuals & SOP's
- Risk Management
- Root Cause Analysis
- Six Sigma Black Belt
- Softgel preparation and manufacturing
- Stability Program
- Statistical Process Controls
- Supplier Management
- Technical System Controls
- Training
- Validation
- Value Stream Mapping
- ISO 13127 CRC; 14644 CR; 11607 & 11737 sterilization and 14971 RM
- Quality management
- Regulatory compliance
- Statistical process control
- Risk assessment
- Audit management
- Continuous improvement
- Supplier quality management
- Customer relationship management
- Process validation
- Team leadership
- Cross-functional collaboration
- Conflict resolution
- Effective communication
- Training development
- Problem solving
- Documentation control
- Product inspection
- Quality metrics development
- Customer complaint resolution
- Six sigma methodologies
Certification
- ISO 9001:2015 Lead Auditor
- ISO 13485 Lead Auditor – current BSI certification.
- CPR/ First Aid certified by the Red Cross
- Six Sigma Black Belt certified – ASQ certification CSSBB
- Manager of Quality/Organizational Excellence – ASQ CQM/OE
Personal Information
Title: Sr. Director of Quality and Regulatory Affairs
Timeline
Sr Director of Quality and Regulatory Affairs
Alltrista Plastics LLC
12.2015 - Current
Director of Quality & Technical Services
Precision Valve North America, Inc.
11.2014 - 01.2016
several positions of increasing responsibility
Nutra Manufacturing (GNC)
06.1997 - 11.2014
Several Positions of Increasing Responsibility
Bausch & Lomb
01.1989 - 06.1997
Associates of Science - Business Management
Greenville Technical College