Jennifer Smith Email & Phone Number

Edmond, Oklahoma, United States

Mange the following Quality Unit Departments: Quality Assurance, Quality Control Laboratory, and Quality Assurance Inspections.• Improved existing quality management systems and structured new quality management systems to enhance compliance.• Implemented regular meetings to manage Quality Events with responsible parties to ensure timely closure and meaningful conclusions.• Created and implemented management of vendor qualifications for manufacturers, contract labs, and service providers andimproved the qualification process of suppliers.• Responsible for hosting, responding to, and managing departments in corrective and preventative to third party and regulatory audits.• Compiled the data submitted to the FDA every 6 months, as required for 503B outsourcing facilities.• Work with interim control personnel on findings and corrections.

Irving, Texas, United States

Manage Quality Assurance, Quality Control, and Quality Management System teams in corresponding functions to support compoundingprocesses and regulatory compliance. Maintain compliance with FDA 503B and cGMP guidelines, state, and federal laws.• Managed initiation and closure of Quality Events such as deviations, investigations, CAPAs, complaints, and non-conformances.• Communicated complaints, product issues, and variances with production and quality unit personnel.• Monitor quality metrics to identify and prioritize continuous improvement opportunities.• Monitored cleanroom activities.• Mentored investigators and technical writers.• Oversaw and managed the supplier qualification, audit, and training programs.• Oversaw batch review and disposition.• Designed, implemented, managed, and enforce site policies, procedures, and documents.• Provided QA oversight of equipment, facility, process validation, requalification program, and validation master plan.• Communicated quality metrics and KPIs in Quarterly Quality Management Review Meetings.• Managed the stability program for new drug development.

Fort Worth, Texas, United States

Dallas, Texas

Lead a team of project managers to maintain existing business and develop new business opportunities for an expanding company. Manage new product development and on-market customer service. Collaborate with departments company-wide to meet deadlines and ensure customer satisfaction. Coordinate weekly business qualification review meetings between R&D, company executives, and client services to discuss potential business opportunities. Create and present a quarterly presentation for the executive team about the growth path and current state of the business.

Dallas, Texas

Led a team of quality inspectors responsible for production process oversight to ensure finished goods met quality standards. Conducted and documented line trials to establish fill weight standards, equipment speeds, and other metrics to determine financial unit cost standards in SAP. Was responsible for documenting deviations and conducting investigations. Wrote and executed rework instructions as necessary. Worked rigorously leading the department and collaborating with management team to improve client relationships and trust.

Irving, Texas

Responsible for maintaining company quality standards. Led a team to manage and improve Quality Systems for Cosmetic and OTCS products. Managed complaints, investigations, QMS such as SOPs and Work Instructions.

Fort Worth, Texas

Responsible for improving quality management system and manage QA approval and oversight of CAPAs, deviations, investigations, risk assessments, etc. Direct and assist departments in implementing meaningful corrective and preventive actions for continual improvement.Oversee Annual Product Reports (APRs). Write and oversee Annual Quality Reports (AQRs) especially when benchmarking a report or procedure. Implement preventive actions to improve quality management systems using the data obtained from event AQRs. Provide QA oversight to departments performing process validations and equipment qualifications. Drive continual process improvements through the CAPA system.Oversee and approve Phase I (laboratory) Investigation by providing feedback on possible root cause and the interpretation of results. Oversee and approve Phase II (Production) Investigations by assisting with root cause analysis and ensuring sound scientific reasoning is applied.Assist management team with processing change controls and directing

Fort Worth, Texas

Conduct and manage internal and external audits and assist in regulatory and customer audits, as necessary.

Fort Worth, Texas, United States

Designed and implemented a highly effective training program to ensure compliance with federal regulations. Wrote and executed new hire, ongoing, and annual trainings which included PowerPoint Presentations, on job training modules, and effectiveness checks. Created annual GMP training scheduling, ensuring all three shifts were trained. Supported production training needs as the company doubled in size.

Fort Worth, Texas, United States

Conduct Analytical Lab Procedures within an FDA and DEA regulated lab, while adhering to cGMP and USP guidelines. Analyze Related Compounds, perform Assay, Identification, Dissolution, Content Uniformity, and Blend Uniformity testing as well as troubleshooting HPLC systems. Compare related compounds stability reports to current analysis for tracking and trending purposes. Interpret, track and trend results for R&D batches to determine whether impurities or related compounds within drug products. Compose necessary change controls to Analytical Procedures and SOPs. Assist Validation Group to write, execute and implement protocols. Designated Code holder for access to controlled substance room.

Austin, Texas

Responsibilities include performing viral marker testing while complying to applicable SOPs ensuring the quality of overall testing integrity. Documentation and interpretation of test results, while gaining experience in identification of anomalies between test result inconsistencies and system conditions. Performing routine maintenance and calibration, while properly documenting the procedures and results.

Austin, Texas

Responsibilities included batch review and release, ensuring adherence to applicable SOPs, monitoring environmental testing conditions, and experience in monitoring and maintaining logs while employing cGMP. Gained familiarity in the verification and requalification of instruments

Waco, Texas, United States

Responsibilities included learning procedures of processing a crime scene, proper collection of evidence, and maintaining the chain of custody. Gained knowledge and practical methods to maintain the integrity of the working environment.