Rhea Proffitt Email & Phone Number

Seal Beach, California, United States

• Performs GMP internal audits, and monitors compliance.• Qualified Trainer. Contributes to training programs.• Batch record issuance • Performs In-process and Final batch record reviews for product release.• Performs disposition of product. • Reviews and analyzes data and documentation. • Quality liaison for production on real time quality issues. Processes deviations and non-conformances.• Writes documents, standard operating procedures, and reports.• Represents department in cross-functional teams, projects, and GXP-related problem resolution.

Seal Beach, California, United States

•Operated in ISO-5 environment on media simulations, clinical and commercial product using aseptic technique. Qualified verifier ensuring steps are completed as per BR and documented using ERPLx.•Active in projects related to continuous process improvement by redlining SOP’s. Involved in the update of the cleaning methodology training procedure.•Led the Manufacturing Team as Point of Contact when Operations Management was unavailable. Communicated issues as needed with other departments, determined severity of issues, and provided real-time instruction to manufacturing personnel.•Qualified manufacturing operations trainer. Trained associates on METrO, Media Simulation, Operator Qualification, Verifier Qualification, and Gowning Qualification.•Represented department in cross-functional teams and projects. Active manufacturing health and safety representative.

United States

•Ensured raw materials are available for production by communicating with QA and materials management department for the on-time delivery of test results and issuance of CoA. •Involved in the creation of new SOP’s and the review, revision or development of new raw material specifications. •Participated in non-conformance investigations providing technical expertise and guidance during material investigations associated with raw materials. •Provided technical expertise and testing support to other departments as part of cross-functional project teams. •Supported raw material activities such as sample and reagent management.