Randy Murray Email & Phone Number

Phoenix, Arizona Area

• Prior to start of a shift, review care giver’s and client’s schedule with Senior Staffing Manager and become aware of any potential trouble spots that might arise during the week and/or weekend.• Answering each incoming call in a friendly, professional, and knowledgeable manner and respond quickly to their needs.• Schedule care giver to Client introductions (CPR) and coordinate with the field representative.• Perform Quality Assurance visits in client’s home as needed.• Fill all Client shifts following designated office scheduling processes.• Communicate changes in Client shifts to the Client(s) and/or care giver(s), Senior Staffing Manager and Care Managers.• Contact designated office backup staff member when questions arise about Clients or care givers that require input.

• Audit Validation Protocols for good documentation practices.• Maintain all documentation pertaining to qualification and validation. • Develop/review requirements and specifications. • Generate validation protocols (IQ, OQ, PQ). • Coordinate the proper approval of plans, requirements, and protocols. • Execute validation protocols. • Prepare validation summary and final reports. • Support the Quality department in any regulatory inspections or audits.• Review change requests to evaluate validation impact. • Coordinate validation execution between all involved departments.• Operate in clean room environments. Certified in:o Aseptic gowning procedures.o Half-Mask.o PAPR

I taught Total Quality Management for the organization as well as over see several process improvemnt initiatives within the framework of what is known as the 100 day workout. My many tasks included:• Process systems Auditor• Responsible for process Improvement initiative via 100 Day Workouts.• Facilitate up to 10 project improvement teams during a 100 Day Workout cycle.• Teach Total Quality Management (TQM) principles to teams running projects as well as senior management.• Teach the use of various quality tools such as:o Systemic Levels of Fixo Cause & Effect Diagramso Process Flowchartso Gantt Chartso Pareto Charts (Pareto Principle)• Process Quality Auditor to ensure processes are in conformance with KidsPeace protocols as well as regulatory requirements.

• Supplier Quality Auditor for routine check-ups or “for cause” issues to ensure materials are manufactured according to organization’s quality requirements.• Assisted in cleaning validation for new equipment.• Responsible for the maintenance, management, and organization of the Quality Assurance Calibration department; ensuring departmental objectives are in line with industry standards.• Responsible for responding to and investigating customer complaints.• Initiate improvements to the quality management system, ensuring compliance to all relevant industry quality standards and regulatory requirements.• Analyze and investigate non-conformance and quality related issues; identify root cause; initiate corrective and preventive actions.• Assist in ensuring company wide departmental understanding and compliance with requirements of ISO 13485, FDA (21 CFR Parts 210 and 211), and cGMP, as applied to the company’s product and processes.• Supervise and direct outside vendors in the performance of contracted services.• Write and maintain procedures relating to the Quality Assurance Calibration function. Prepare and present reports, data, and Key Performance Indicators, to senior management. • Review document change control requests, ensuring compliance with ISO, FDA, and cGMP industry standards.• Conduct internal and external audits.

• Ensured manufacturing documentation was in compliance with FDA and cGMP requirements.• Reviewed, edited, and formatted manufacturing batch records.• Prepared and presented technical reports to senior scientists and supervisors. • Investigated quality issues and document findings, reported in both written and verbal form to management.• Managed product release process with internal and external customers.• Assisted with internal and external audits.• Wrote, maintained, audited, and archived batch records and SOP’s to support pharmaceutical manufacturing activities.

Bs, Business

Diploma, General