Mina Labib Email & Phone Number

Aliso Viejo, Ca, Us

San Jaun Capistrano

San Juan Capistrano, California, United States

Provide technical oversight of area(s) of responsibility and serve as a technical resource for problem solving and process improvement to ensure accurate test performance.Devote time to direct specimen testing/troubleshooting as needed to maintain adequate workflow.Use effective two-way communication in leading/participating in general laboratory/section meetings.Support, implement, and ensure compliance with all department and company policies and procedures.Monitor and ensure implementation of goals to meet established quality assurance, quality control, and quality improvement plans.Ensure compliance with all regulatory agency requirements through documentation, audits, and corrective action.Interact with internal and external customers to ensure proper sample handling and reporting.Participate in the updating of departmental standard operating procedures and database to accurately reflect the current practices.Maintain adequate staffing by interviewing, hiring, training, and competency assessment of personnel.Perform the scheduling, planning, staffing, and monitoring of workflow to meet established goals.Provide staff development through performance development and review and corrective counseling.Procure appropriate supplies and equipment to maximize department efficiency and meet established budgetary and quality goals.

Supervisory responsibilities.

Quest Diagnostics

Interact with Pharmaceutical clients to provide scientific/technical consultation for analytical validation and testing.Planning, assigning, and directing statistical experimental design of new test development and technology transfer with the ability to develop, document, and validate analytical and clinical testing methods.Define, coordinate, and monitor quality assurance (QA) programs. Ensures quality control (QC) and compliance procedures are followed and QC reports are up to date. Follow up with regulatory issues pertaining to clinical trial test performance. Mentor and support direct reports in their responsibilities and functions, ensuring they receive training and development. Identify and implement training programs as necessary Oversee staffing of all personnel. Effectively maintains quality staffing by interviewing, hiring, training, and providing staff development through performance evaluation and corrective action.Review test performance, drive process and project management, prepare and submit required technical documents (validation summaries, analytical reports, database information, input forms, etc.) to meet established deadlines for clinical trial clients.Ensure department standard operating procedures accurately reflect the current process and meet FDA medical device class II requirements.Develop annual budget and manage department costs and resources to adhere to budget.Manage, define, coordinate, and monitor production line.Ensure EHS regulatory standards and safety procedures are followed by all staff to provide a safe working environment.

Lead the manufacturing team, through out the reagent formulation, preparation, filling, labeling and packaging. Actively support and interact with material management, quality assurance, quality control, product support, R&D, technical service and customer service.Assist the regulatory submissions team in the preparation and submission of regulatory, marketing applications, and product registrations.Assist in representing the company before US and international regulatory authorities. Assist in managing the maintenance of regulatory affairs files and distribute information as required to support key stakeholders.

Lead cross-functional teams through research, development, manufacturing scale-up product improvement and post marketing product support for numerous new products. Direct the activities of scientific staff. Launch new products, reduce labor costs by launching esoteric immunoassays on an automated system.Work with internal engineers on test protocols and test requirements as specified by regulatory health authorities and notified bodies.Assist in ensuring compliance to the Medical Device Directive (MDD) and to design control regulations during product development and delivery activities. Provide input to engineering teams to assure that worldwide regulatory requirements and standards are incorporated in the product development process and design/manufacture of the products.Participate in the engineering change order process, by reviewing engineering and manufacturing document release and changes, as requested.