United States
I am a bilingual and multicultural associate with supervisory experience. I have coordinated and supervised activities to achieve the mission, vision, and goals of the organization. I also enjoy being part of a health care team that collaborates together in order to improve patient quality care and safety. Specialties: Bilingual: fluent in both English and Spanish Basic knowledge of French Quality assurance experience in medical device and pharmaceutical industry Validation experience in pharmaceutical industry
Mentored and trained new engineers by providing guidance to them during executions and in drafting validation documents. Acted as a liaison between management and PV team to provide updates and troubleshoot/resolve challenges presented during formulation activities. Drafted and executed validation documents in support of expansion facility activities. Collaborated in editing templates for PV protocols, SOP documents, validation batch records via change controls and reviewing protocols. Evaluated deviations and CAPAs to determine quality impact on drug products. Performed process validation for products in manufacturing facility. Supported product transfer of commercial products from current facilities to new state of the art equipment and facility.
Coordinated validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation. Coordinated documenting activities via protocols and summary report templates to help establish new templates and policies as needed. Reviewed facility changes and provided input on re-validation. Assessed risks involved in processing steps and related to equipment. Developed and/or reviewed validation requirements and designed deliverables. Monitored validation strategies. Ensured polices were followed and conducted validation studies in accordance with batch records/protocols. Identified exceptions associated with validation protocol execution. Worked directly with clients to provide exceptional service in delivering high quality products.
Processed and investigated customer complaints to determine root cause(s). Ensured accurate documentation of the complaint evaluation and investigation results within assigned complaint records. Reviewed complaint investigations for accuracy and completeness and in-house documentation. Conducted and documented moderately complex investigations including data collection, summary and initial analysis. Conducted escalated investigations from complaints. Supported trending and analysis of complaint data to ensure appropriate actions were taken. Escalated potential product performance issues or quality system issues. Performed specialized tasks as trained in an independent fashion, requiring minimal direction, once procedures were established. Maintained records of procedural documents in accordance with good documentation practices (GDP). Generated written reports as required to document complaint investigations and/or projects. Provided recommendations and observations to senior quality staff on results of projects/tasks. Knowledgeable of federal and other regulations, e.g. QSRs, ISO and ISO 13485. Carried out duties in compliance with established business policies. Demonstrated commitment to the development, implementation and effectiveness of FDA and other regulatory agencies. Responsible for exhibiting professional behavior with both internal/external business associates that reflected positively on the company and was consistent with the company’s policies and practices. Understood and was aware of the quality consequences which may have occurred from the improper performance of their specific job. Had awareness of device defects that may have occurred in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Played central role in achieving candidacy and accreditation for the program to ensure quality education was being provided. Coordinated the acquisition process of medical equipment and computer software programs. Reviewed potential suppliers of medical equipment. Created and updated the program’s budget spreadsheet for the academic year. Member of the Appeals Committee which dealt with student dismissals and appeals. Supervised and trained student aid workers. Provided IT support to faculty and students. Inputted course schedules and retrieved student information from CampusVue software program. Posted course content on Blackboard software program. Processed orders by using E-requester software program. Assisted Payroll department with faculty, adjunct, and student aid workers’ time sheets on ADP software program. Handled faculty reimbursements through Concur software program. Managed student applications, transcript evaluations, student questions and student/faculty interviews. Coordinated information sessions, meetings and other program events. Managed faculty meeting minutes, faculty schedules and hotel/transportation reservations. Handled confidential faculty and student information.