Highly effective and innovative Quality Assurance Manager with extensive experience in all phases of quality control, quality assurance, and research & development. Demonstrates exceptional problem-solving, communication, and organizational skills to effectively lead management, cross-functional, and operational teams. Identifies and implements best practices to drive optimal performance. Proven ability to develop strategic process solutions that enhance operational results.
Hi, I’m
Theresa Speights
New Freedom,PA
Summary
Overview
21
years of professional experience
1
Certification
Work History
Oakworks Medical
Quality & Regulatory Manager
10.2022 - 02.2025
Job overview
- Worked with governance committees to make and evaluate plans.
- Oversight of 100 operations and quality personnel
- Maintained and developed budgeting plans for Quality.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Consolidated global information relevant to medical devices and monitored global submissions and approvals status.
- Recommended improvements to processes.
- Represented company in global industry communications with regulatory agencies.
- Consulted with regulatory representatives to manage filings, applications, and reports.
- Adhered to state and federal requirements for Class I and II medical device registrations.
- Provided responses to regulatory agencies regarding product information or issues.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Directed documentation efforts to comply with domestic and international regulations and standards.
- Proven ability to develop and implement creative solutions to complex problems.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
Wm. T. Burnett
Quality Assurance and Quality Control Manager
10.2020 - 07.2022
Job overview
- Directed quality and operations personnel
- Lead highest priority multi-million dollar contracts and served as direct liason.
- Implemented quality assurance process to inspect, test, and evaluate products reducing customer credits by 50% in less than 6 months.
- Developed product testing of new products, verifying adherence to the highest standards of safety and quality and reducing rework by 70%.
- Identified and implemented quality control systems based on data collected from productivity reports.
- Monitored operations output by organizing and prioritizing work according to deadlines, speeding up the process by 60%.
- Ensure the quality of final products by training cross-divisional line staff on best practices and conducting periodic quality assessments, strengthening overall QA capabilities.
- Created QA procedures to eliminate products that are not up to standards and identify the reasons for product issues.
- Reduced anticipated budgeting plan and allocated towards necessary training for quality personnel.
- Modified and created necessary SOP's and provided training for the entire organization.
- Conducted risk assessments to identify and mitigate potential quality issues.
- Created and maintained quality management systems to align with industry standards.
- Chaired quality review meetings to review the effectiveness of performance.
- Established and tracked quality department goals and objectives.
- Applied coaching techniques and tools to support managers and team members.
ALYS Consulting
Manager of Operations
06.2015 - 10.2020
Job overview
- Managed at least 20 responses to customer quality complaints weekly and provided resolutions.
- Executed management tasks to ensure proper compliance with the state and regulatory affairs.
- Developed presentations for customers
- Determining and implementing policies and making decisions
- Preparing and filing statutory documents with the Companies Office or other agencies
- Travel for conferences to present new opportunities with various vendors
- Identified plans and resources required to meet project goals and objectives.
POMPEIAN OLIVE OIL Co. (Aerotek Scientific)
QC Chemist /Supervisor
05.2013 - 06.2015
Job overview
- Lead investigator and customer complaints to determine root cause and corrective actions.
- Wrote and/or standard quality control operating procedures.
- Served as a technical liaison between quality control and other departments, vendors, or contractors.
- Resolved customer complaints regarding services, products, or personnel.
- Built solid relationships with quality and operations personnel.
- Planned and prepared work schedules and assigned employees to specific duties.
- Trained personnel to be audit ready under specific compliance FDA, USDA, and BRC standards.
- Communicate effectively with all levels in the organization.
Coca-Cola Beverages Northeast
Quality Control Chemist
09.2013 - 05.2014
Job overview
- Reported to corporate my findings on all analytical testing that was critical of releasing any product.
- Prepared documents, such as standard operating procedures, manufacturing batch records, inventory reports, or productivity reports
- Provided progress reports to operations.
- Responsible for Quality Assurance of the products produced at the facility
- Ensured products consumable stayed within compliance before it reaches the consumer.
W.R. Grace Davison (Kelly Scientific)
Quality Control Chemist
11.2011 - 09.2013
Job overview
- Collaborated with chemists, production personnel and customers to improve product quality and functionality.
- Advised management on existing and emerging quality control methods to enhance testing and research capabilities.
- Prepared and standardized test equipment, test solutions and reagents to enable successful testing completion.
- Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
- Modified and adapted standard methods and procedures to solve analytical problems.
- Contributed to team discussions and new project initiatives to advance progress and optimize profitability.
MARTEK BIOSCIENCES CORP.
Quality Control Chemist
09.2005 - 10.2011
Job overview
- Leading chemist overseeing the stability and development of Omega-3's into food and beverage models that exist today.
- Planned, executed, testing and its impact on stability.
- Conducted clinical evaluations and studies
- Developed accelerated methods to predict product launches.
- Authored Project Summary Forms to manage patent filings.
- Managed an integrated project team engaging with personnel from foreign organizations
- Conducted investigative reports for leadership meetings.
- Trained engineers on new SOP and created new SOP's.
W.R. Grace(Contract W/On Assignment Lab Support)
Quality Assurance Analyst
09.2004 - 09.2005
Job overview
- Provided high efficiency results within specific guidelines
- Trained to work safely with corrosive and carcinogenic materials
- Reported progress, test metrics and results to project stakeholders.
- Supported company in maintaining work environment focused on quality, communication, collaboration, integration, and teamwork.
- Interpreted test results by comparing to established specifications and control limits.
- Made recommendations on appropriateness of data for release.
- Reported problems and concerns to management.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
McCormick (Contract W/On Assignment Lab Support)
Quality Control Analyst
12.2003 - 08.2004
Job overview
- Monitored and maintained calibration program.
- Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
- Provided regular updates to leadership on quality metrics by communicating issues or deficiencies and resolutions.
- Developed quality assurance SOP's.
- Analyzed quality and performance data to support operational decision-making.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
- Liaised between quality control and other departments and contractors, providing project updates and consultation.
Education
MORGAN STATE UNIVERSITYBaltimore, MD
Bachelor of Science from Chemistry
05.2003
University Overview
Skills
- Asset Management
- Excellent communication skills
- Regulatory Compliance
- Project Leadership
- Excellent Documentation Practices
- Records Management
- Strategic Planning
- Product development
- New Product Development & Legal Patent
- Regulatory research, compliance, and policy
- Cross-functional team leadership
- Audits and ISO standards
- License renewals
- Strategy development
Additional Information - Technical And Experimental Skills
Additional Information - Technical And Experimental Skills
- Clinical Research- Adherence to Investigative Clinical Research (ICR), Clinical study Reports according to (ICH Guidelines), Good Clinical Practices (GCP), and Good Clinical Research Practice (GCRP).
- Chemical Analysis/Assays- GC, HPLC, UV Vis, OSI, Mass Spectrometer, Turbiscan, Centrifuge, IR and NMR Spectrum. Instrument calibration and maintenance, viscosity testing, computational chemistry, purification, titrations, and extractions. Dissolution testing, solution preparation, pipetting, molecular weight determination, polymer identification, and wet chemistry. Brix, Phosphate assay, Seam check, Sensory, and Density testing.
- Personal Computing- Proficient with Lotus Notes, SAP, Stat Pac, Lims, Genesis, Microsoft Office including Excel, Power Point, Word, Chemstation, and Outlook.
- Professional Training- Attended a Minitab Analysis Workshop in Columbia, MD 2009. Trained in- Key Performance Indicators (KPI), Good Laboratory Procedures (GLP), Hazard Analysis Critical Control Point (HACCP), Good Manufacturing Practices (GMP), Allergens and Production, and Near-Miss Basic Reporting.
Awards
Awards
- Lead cross functional leaders that developed ground breaking product linked to slowing progression of Alzheimer's
- Developed a scientific model to decrease shelf life failure rates from about 80% product failures to product passing to 100%.
- Co-author on several patent applications marked as trade secrets.
- Served as lead scientist on multi-million dollar project working with an international customer that led to a patent and commercialization.
- Exceeded Quality Control goals of internal/external audit by 95%.
- Managed and trained leadership personnel on successful audit readiness plans to maintain FDA compliance certifications
Groups
Groups
- American Oil Chemical Society (AOCS)
- Institute of Food Technology (IFT)
Affiliations
Affiliations
- Black Women In Clinical Research Regulatory Affairs Network
- Chemistry & Engineering Club MSU
- NAACP DC Chapter
Certification
- ISO 9001, 2015 Lead Auditor Training
- Certified Quality Auditor (CQA)
- HACCP Training
- Good Clinical Practice Certification (GCP) - Various clinical research training organizations.
- Corporate Compliance and Ethics Professional
- CQM - Certified Quality Manager
Timeline
Quality & Regulatory Manager
Oakworks Medical
10.2022 - 02.2025
Quality Assurance and Quality Control Manager
Wm. T. Burnett
10.2020 - 07.2022
Manager of Operations
ALYS Consulting
06.2015 - 10.2020
Quality Control Chemist
Coca-Cola Beverages Northeast
09.2013 - 05.2014
QC Chemist /Supervisor
POMPEIAN OLIVE OIL Co. (Aerotek Scientific)
05.2013 - 06.2015
Quality Control Chemist
W.R. Grace Davison (Kelly Scientific)
11.2011 - 09.2013
Quality Control Chemist
MARTEK BIOSCIENCES CORP.
09.2005 - 10.2011
Quality Assurance Analyst
W.R. Grace(Contract W/On Assignment Lab Support)
09.2004 - 09.2005
Quality Control Analyst
McCormick (Contract W/On Assignment Lab Support)
12.2003 - 08.2004
MORGAN STATE UNIVERSITY
Bachelor of Science from Chemistry
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