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.

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.
• 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.

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.

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.

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).

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.

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.

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.

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.