THEAQUIATA MITCHELL
Memphis,Tennessee
Summary
Quality professional with experience in Regulatory Compliance in 503B, Over the Counter Pharmaceutical Manufacturing, Medical Device, Tissue, Environmental, and Health Care product industries. Top-notch Quality Assurance and Control professional with proven track record of success leading and growing organizations. Strong background in strategic planning, financial management and team development. Skilled in identifying opportunities and implementing practical business strategies with commitment to staying informed with changes in regulatory guidelines, technologies, automation, and best practices.
Overview
23
23
years of professional experience
Work History
Senior Vice President of Quality
Wells Pharma of Houston, LLC
09.2023 - Current
- Manage a staff of Quality Control, Quality Assurance, EHS, and Validation professionals
- Developed Pharmaceutical Quality Systems, manage the qualification of all equipment and the commissioning of the facility
- Responsible for the review and approval of all Confidential documentation relating to the facility, processes, and products
- Development and Approval of all SOPs for start-up of the facility
- Developed Vendor Qualification program to ensure the integrity of all pharmaceutical products and materials
- Directed the Quality Department to include Performance Improvement, Risk Management, Quality Assurance, and Test Automation
- Completed FAT on automated equipment domestic and international
- Manage the initiation and closure of Deviations/ Investigations, CAPAs, Change Controls with thorough supporting documentation
- Collaborate with other members of management to develop new products, processes and people
- Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
- Prepare and submit monthly / quarterly reports and trending of data to identify and prioritize continuous improvement of processes and procedures
- Lead internal and external (customer/state of pharmacy /regulatory) cGMP inspections / audits
- Successfully completed a 11-day FDA Onsite Inspection with only one (1) 483 finding in 2021
- Successfully completed a 13-day FDA Onsite Inspection with three (3) minor observations (483) findings in 2022
- Successfully completed 2020 and 2022 DSHS inspections with one minor observation on each inspection
- Successfully completed Texas Board of Pharmacy inspections 2020, 2021, 2022 and 2023
- Successfully completed California Board of Pharmacy inspection for 2022, 2023, and 2024
- Successfully nominated a drug on the FDA Bulk Drug Shortage List for an annual profit of $15M
- Successfully validated a cleaning process to manufacture Cephalosporin production
- Proficient at providing an implementation plan in response to an observation for internal or external observations
- Automation sourcing, review and or approval of source documents and qualification of equipment.
- Hired and managed employees to maximize productivity while training staff on best practices and protocols.
- Delivered exceptional customer service by implementing best practices and fostering a culture of accountability within the organization.
- Developed and executed strategic initiatives to drive business growth, resulting in higher revenues and market share expansion.
- Collaborated with executive leadership team members on long-term strategic planning that ensured sustainable success for the company.
- Maintained consistent growth in revenue, contribution margin, operating profit, and EBITDA.
- Restructured departments for increased efficiency, optimizing resource allocation and improving communication between teams.
- Championed innovation by encouraging cross-functional teams to pursue creative solutions to complex challenges.
Vice President of Quality
Wells Pharma Of Houston, LLC
09.2021 - 09.2023
- Cultivated strong relationships with key stakeholders, including customers, vendors, and regulators to promote collaboration and long-term success.
- Led cross-functional teams for the successful completion of major projects, resulting in increased efficiency and client satisfaction.
- Demonstrated proficient leadership skills to motivate employees and build competent teams.
- Collaborated with senior management to develop strategic initiatives and long term goals.
- Established performance goals for department and provided methods for reaching milestones.
- Maintained manufacturer/pharmacy license to distribute to all US states, including Washington, DC.
- Monitored industry trends, keeping current on latest changes and competition in industry.
- Clarified roles, responsibilities and expectations of staff.
- Hired and managed employees to maximize productivity while training staff on best practices and protocols.
- Developed new revenue streams by identifying growth opportunities.
- Participated in FDA, DSHS, Texas BOP, and California BOP onsite inspections as Site Quality Head with minimal observations.
- Ensured aseptic environment is maintained in a state of control through continuous monitoring of the building monitoring system.
- Implemented a site safety team which employed optimal safety practices to reduce worksite complaints and hazards.
Director of Quality
Wells Pharma Of Houston, LLC
05.2020 - 08.2021
- Collaborated with suppliers to enhance their understanding of our quality requirements, fostering strong relationships built on trust and transparency.
- Ensured adherence to ISO 9001 standards throughout all processes, reinforcing a company-wide commitment to quality excellence.
- Built strong partnerships with key stakeholders, enabling increased collaboration on problem-solving efforts and overall process improvements.
- Conducted root cause analysis for product defects and implemented corrective actions, resulting in reduced return rates and increased customer satisfaction.
- Led a cross-functional team to develop and execute comprehensive quality assurance plans for products and services.
- Streamlined internal audit procedures by developing standardized templates for reporting findings efficiently and consistently.
- Enhanced customer complaint resolution processes, expediting response times and corrective action.
- Directed quality assurance teams, quality control team, validation team, and visual inspection team to provide a better turnaround times and reduced customer complaints.
- Authored documentation for internal use by QA personnel, setting guidelines for review activities and reporting requirements for deviations, OOSs, and CAPAs.
- Participated in FDA, DSHS, and Board of Pharmacy inspections as Site Quality Head with one or less observations.
Associate Director of Quality Assurance and Validation
Wells Pharma of Houston, LLC
01.2020 - 05.2020
- Experienced in Validation of manufacturing processes, cleaning procedures, equipment qualification and computer software
- Able to write validation protocols, execute protocols and generate reports
- Able to review analytical and manufacturing data for compliance to policies and procedures as well as FDA and ICH guidance
- Able to identify gaps in our current Quality System and implement new processes and procedure to achieve compliance
- Experience with internal and external customer/agency audits for cGMP compliance
- Experience with regulatory filing (Drug Master Files with FDA).
Validation Manager
Cognate BioServices, Inc.
10.2017 - 03.2020
- Develop and review IQ/OQ/PQ documents related to Thermal Mapping and production/laboratory equipment and instruments to ensure compliance to regulatory requirements, internal company standards (SOPs), and current industry practices (cGMP)
- Oversee the execution of Computer System Validation (CSV) qualifications
- Approval of work orders in Blue Mountain Regulatory Asset Manager (BMRAM) system to support the Facilities Department
- Manage and supervise a team of eight in the creation of protocols, execution of qualifications, review of the executed documents and summary report
- Technical writing of qualification documents, non-conformances, CAPAs and client memo
- Performs Impact Assessments on Equipment/Instruments/Systems (EI) to determine the level of qualification necessary to maintain the integrity of the processes in which the EI is utilized
- Evaluates data generated during temperature distribution studies through the use of related computer software and prepare data summaries
- Authored and remediated procedures (SOPs), protocols, and forms
- Performed in process and final release quality inspections of qualification
- Qualified temperature-controlled equipment such as 2-8C refrigerators, -20C, -30C, -80C freezers, CO2 incubators, and Creo-Freezers utilizing the Kaye Validator system
- Qualified other lab equipment such as centrifuges, biological safety cabinets, and cell counters
- Compiled and Analyzed validation data, prepared reports, and made recommendations for changes and/or improvements
- Oversee the work of the Validation Specialist and Computer System Validation Specialist
- Manage the validation schedule for the equipment/systems/utilities/facility
- Payroll and scheduling of associates.
Quality Assurance Supervisor
Millstone Medical Outsourcing, LLC
05.2014 - 11.2017
- Assist the Quality Director in the management of both domestic and foreign non-conformances in order to provide an effective corrective action
- Oversee the quality aspect of the project area to ensure that training, processes, and procedures are aligned with the client's request
- Oversee the distribution area to ensure that all employees are in compliance with policies, procedure and regulatory standards for shipping both domestic and international orders
- Work in collaboration with other members of the Quality Department to prepare for and host (if needed) internal and external auditors
- Assist other members of the Quality Department and facility management team to ensure timely closure of any audit observations
- Ensure that corrective action plans are implemented and followed up for effectiveness
- Conduct thorough investigations to accurately identify non-conformances and deviations in policies and procedures
- Maintain and manage the Quality System for traceability of all non-conformances by assigning issue per the procedures for immediate investigation and disposition
- Assist with the logging, trouble shooting, investigation and progression of issues with non-conforming product, processes or work in a timely manner
- Review validations for accuracy and completion (IQ, OQ and PQ)
- Ensuring that products conform to established requirements and standards through appropriate audit, inspection, and test activities
- Perform physical inspection of products and comparison/assessment to all related documentation within the warehouse as needed
- Technical writing of various documents including but not limited to procedures, protocols, internal assessment reports, audit observation responses, and non-conformance reports, engineering change controls, process flow mapping and PFMEAs
- Maintaining an interdependent relationship with the functional areas within the facility and engage in cross-functional collaboration
- Familiar with Oracle, ERP, SAP, Agile, and Microsoft Office (Word, Outlook, PowerPoint, and Excel)
- Experienced with FDA, VAWD, and ISO 13485:2003 regulations for Tissue Licensing and Medical Devices.
Lead Chemist
GlaxoSmithKline
10.2007 - 07.2014
- Ensured that the highest quality testing was performed in compliance with FDA and GLI specifications, protocols, cGMP and safety regulations
- Performed raw material, intermediate and finish goods testing procedures in accordance to USP, FDA, and SOPs
- Provided a well-developed training program which included both laboratory safety and testing procedures
- Supervised chemist in performing both quantitative and qualitative testing for product release
- Initiated laboratory investigations for all non-conforming products
- Analyzed the product by using various instruments for identification (GC, HPLC, IR, UV-VIS, AA, FTIR, Karl Fisher and Auto titrators)
- Competent in working with related software package needed to analyze samples (Empower, Microsoft Office, etc.)
- Assisted in the validation of products and equipment
- Performed technical writing of protocols, SOPs, procedural revisions and training modules
- Safety Coordinator for the Quality Department (recording near miss, performing risk assessments, monitoring PPE usage and conducting monthly safety meetings)
- Familiar with LIMS, Empower, Urochrome, Microsoft Word, Excel, Outlook, and PowerPoint.
- Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
- Enhanced product quality by developing and optimizing chemical processes and procedures.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
- Mentored junior chemists, providing guidance on industry best practices and career development opportunities.
Lead Chemist
KIK Custom Products
09.2011 - 09.2012
- Perform various assignments within the Quality Lab to support production to ensure that the highest standards are met by testing raw materials, intermediate and finished goods using a variety of qualitative and quantitative techniques
- Provided supervision, training while managing the work flow to ensure that testing was completed per manufacturing schedule
- Analyzed the product by using various instruments for identification (HPLC, IR, UV-VIS, Karl Fisher and Auto titrator)
- Competent in working with related software package needed to analyze samples (Empower, Microsoft Office, etc.)
- Strong interpersonal and communication skills necessary to interact with internal and external customers
- Complying with company GMP, GLP, and Safety Policies and Procedures.
Contract Chemist
Pharmedium /Aerotek
01.2011 - 07.2011
- Assist in routine testing procedures in accordance to USP, FDA, DEA and SOPs
- Analyzed Schedule I and II USP standards and samples (Hydromorphone HCl, Midazolam, Morphine Sulfate, Ephedrine, Phenylephrine)
- Tracking and traceability of the usage of USP Standards for Controlled Substances
- Destruction of expired controlled substances
- Maintained the chemical inventory list consisting of USP Schedule II standards
- Consistently maintaining Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP).
Chemist
Buckman Laboratories
10.2001 - 10.2007
- Analyze product samples through extensive use of Karl Fisher, Auto titrator, FTIR, UV-VIS, GC, and HPLC on all batches, intermediate and final stages
- Prepared all internal and active standards using manufacturer supplied reference standards
- Prepare and present oral and written analyses of lab results
- Able to measure instrument variations and apply corrections for ensure accuracy and precision of various instruments and measurement tools
- Research and resolve internal and external customer inquiries including generating C of A's
- Strong knowledge of ISO 9001:2000 and Environmental, Health and Safety Policies and Procedures.
Education
Masters of Science - Occupational Safety and Health
Columbia Southern University
Orange Beach, AL02.2017
Bachelor of Science - Occupational Safety and Health
Columbia Southern University
Orange Beach, AL10.2015
Bachelor of Science - Biology
University of Memphis
Memphis, TN08.2005
Skills
- SStrategic leadership
- Policies and Procedures
- Operational Excellence
- KPI Tracking
- Investigations (CAPA, Deviations, and OOS)Staff Development
- Revenue Generation
- Recruiting and Hiring
- Analytical and Critical Thinker
Timeline
Senior Vice President of Quality
Wells Pharma of Houston, LLC
09.2023 - Current
Vice President of Quality
Wells Pharma Of Houston, LLC
09.2021 - 09.2023
Director of Quality
Wells Pharma Of Houston, LLC
05.2020 - 08.2021
Associate Director of Quality Assurance and Validation
Wells Pharma of Houston, LLC
01.2020 - 05.2020
Validation Manager
Cognate BioServices, Inc.
10.2017 - 03.2020
Quality Assurance Supervisor
Millstone Medical Outsourcing, LLC
05.2014 - 11.2017
Lead Chemist
KIK Custom Products
09.2011 - 09.2012
Contract Chemist
Pharmedium /Aerotek
01.2011 - 07.2011
Lead Chemist
GlaxoSmithKline
10.2007 - 07.2014
Chemist
Buckman Laboratories
10.2001 - 10.2007
Masters of Science - Occupational Safety and Health
Columbia Southern University
Bachelor of Science - Occupational Safety and Health
Columbia Southern University
Bachelor of Science - Biology
University of Memphis
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