CARLA WILLIAMS
Arlington
Summary
Quality professional with 25+ years of experience and excellent analytical and interpersonal skills. Expertise in quality assurance / control, cross-training of employees, auditing, and recruiting. Proven ability to develop and maintain excellent client relations, develop and lead high-performing, cross-functional teams, and develop process improvements that save time and reduce costs.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager
Aloe Vera of America, Inc.
Dallas
01.2018 - 01.2024
- Responsible for leading the development and execution of Quality Assurance programs and verification activities that ensure compliance with company policies, food safety standards, government regulations, and industry best practices including cGMP, FSMA, and HACCP.
Document Control Supervisor
Aloe Vera of America, Inc.
Dallas
01.2016 - 01.2018
- Responsible for leading, maintaining, facilitating, and sustaining all CAPA, Change Control, and Document Control programs.
- Compile and review KPIs and Quality Department metrics and assist with managing the timelines for meeting objectives.
- Assist the Quality Director in composing and compiling Quality Agreements.
- Participate in continuous improvement initiatives to maintain cGMP compliance, improve product quality, production efficiency, and reduce finished product rejects.
Documentation Specialist
Colgate Oral Pharmaceuticals
Dallas
01.2013 - 01.2016
- Responsible for issuing, maintaining, controlling, and auditing documentation for cGMP compliance and managing the change control program.
- Created and maintained Standard Operating Procedures for the cGMP compliance programs, manage libraries of SOPs, Formulas, Process SPIs, general SPIs and RMPs to ensure accuracy and reliability.
- Audited all documentation required to support the oral care business.
- Developed and managed a file system for current and archived documents required for cGMP compliance.
- Assured cGMP documentation training was provided to new employees and as part of annual training.
- Participated in internal and external audits as part of the plant’s GMP and Quality Team.
Quality Assurance Manager
Semen and Sperm Detection Inc.
Euless
01.2012 - 01.2013
- Responsible for the quality system of the laboratory.
- Performed the duties of a forensic technician.
- Monitored laboratory practices to verify continuing compliance with policies and procedures.
- Periodically assessed the adequacy of report review activities.
- Ensured the validation of new technical procedures.
- Proposed and implemented corrections and improvements in the quality system.
- Investigated technical problems, proposed remedial actions, and verified their implementation.
Clinical Operations Supervisor
Covance
Dallas
01.2007 - 01.2012
- Supervised a staff of 12-15 individuals, comprised of medical staff and research technicians.
- Ensured that the safety, welfare, and dignity of research subjects was not compromised.
- Ensured that the quality of service provided by team members met the requirements of both internal and external clients.
- Maintained current knowledge of ICH/GCP standards.
Education
M.B.A. - Management
University of Phoenix
Dallas, TexasB.S. - Biology
Delta State University
Cleveland, MississippiSkills
- Microsoft Office
- MS Outlook
- Word
- Excel
- Power Point
- Access
- Ensuring
- 5S
Certification
- FSPCA Preventive Controls for Human Food, 02/01/19
- Foreign Supplier Verification Programs, 02/01/19
- Hazard Analysis Critical Control Point (HACCP), 11/01/18
- ISO/IEC 17025:2017 The New Standard for Laboratory Competence Course, 09/01/18
- Management Systems Auditing (BSI), 01/01/18
- Quality Management Systems (BSI), 01/01/18
- Leading Management Systems Audit Teams (BSI), 12/01/17
- ISO 9001: 2015 Lead Auditor (BSI), 01/01/18, 8762813-180338
Additional Work Experience
- Semen and Sperm Detection (SSDI), Euless, TX
- Covance, Dallas, TX
- UT Southwestern Medical Center, Dallas, TX
- Pharmchem Laboratories, Ft Worth, TX
- Clinical Lab Staff, Ft Worth, TX
- SmithKline Beecham, Dallas, TX
Timeline
Quality Assurance Manager
Aloe Vera of America, Inc.
01.2018 - 01.2024
Document Control Supervisor
Aloe Vera of America, Inc.
01.2016 - 01.2018
Documentation Specialist
Colgate Oral Pharmaceuticals
01.2013 - 01.2016
Quality Assurance Manager
Semen and Sperm Detection Inc.
01.2012 - 01.2013
Clinical Operations Supervisor
Covance
01.2007 - 01.2012
M.B.A. - Management
University of Phoenix
B.S. - Biology
Delta State University
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