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Quality Audit Specialist

Company: Abbott
Location: Fresno
Posted on: March 24, 2020

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.Job Summary:Working without appreciable supervision in accordance with established policies/procedures, fulfills the quality assurance unit function for a non-clinical testing research facility to ensure compliance with applicable regulatory requirements, Good Laboratory Practices (GLP) standards and CPH3 policies and practices. Applies business knowledge and/or principles/methods normally acquired in a recognized four-year course of study. Recommends interprets and implements CPH3 specific policies and procedures to accomplish assignments; resolves a broad range of issues and problems. Identifies and routinely uses the most effective, cost efficient, and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Promotes the process of continuous quality improvement and coordinates solutions for quality assurance audits. Exercises sound judgement in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Remains current on developments in field(s) of expertise.Essential Functions:Audits for accuracy of calculations and proper data recording, and assures that studies were performed in compliance with study protocols, Standard Operating Procedures (SOPs), and applicable regulations. Reviews study specific data prior to or after critical phase inspections; performs critical phase inspections. Audits study reports to assure that the reports comply with applicable regulations, describe the study methods and accurately reflect the data. Review reports, protocols, and amendments for accuracy and for compliance with U.S. guidelines. Prepares and signs Quality Assurance statements as required to be included in audited final reports. Performs inspections of internal facilities and of contractors facilities and procedures for GLP compliance. Assists with client and government inspections. Performs reviews on equipment logs, and equipment (including applicable computer systems) validation / qualification documentation. Schedules and tracks quality assurance audits, inspections and findings. Assists with coordinating and scheduling departmental activities. Updates and maintains required internal and external audit programs for laboratory, GLP training, and document control. Maintains written and signed records of auditing activities and submits written reports to management and study director. Maintains copies of current protocols for assigned studies. Maintains training records and archives for future reference.Other Duties: Number and list important but non-essential and/or infrequent duties performed.Conducts special analyses and projects as required. Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that may affect medical research activities. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences. Resolves and/or facilitates resolutions, and by attending conferences. Performs training to CPH3 staff on GLP regulations and compliance. Performs related duties, on occasion, as assigned or required.Accountability/Supervision: Describe the significant problem solving/decision making responsibilities. Describe the type and extent of supervision received and exercised.Working without appreciable supervision in accordance with established policies/procedures is accountable for the quality assurance unit function in a non-clinical research facility; ensuring compliance of auditing activities with federal regulatory requirements and with Company policy and procedure. Has knowledge of, and conforms to, all relevant safety information within his/her area of responsibility. Responsible for SOP development and updates. May provide substantial input to research standards, practices, procedures and policies. Proactively identifies and shares opportunities, concerns, and solutions with coworkers. Decisions and recommendations have critical impact on significant organizational projects or operations. Identifies the components of work assignments and allocates time appropriately based on priorities. Identifies relevant sources of information and utilizes them to make decisions. Acts as mentor/coach to laboratory personnel to develop solutions and resolve complex problems that could significantly impact organizational commitments. Uses best business practices to ensure success of work assignments and/or projects. Applies initiative and judgement in accomplishing resolution of unusual situations. Resolves complex problems and develops original solutions.Relationships:Internal: Interfaces primarily with Research Facility Management, Study Director, lab personnel, Sponsor Representatives and Sponsor Quality Assurance Department. May have internal contacts, at various levels, with Clinical Research, Research and Development and Manufacturing to gather or convey information related to non-clinical research studies. May participate on one or more project teams; provides guidance to laboratory employees. Represents the organization and resolve problems/determine priorities. Mentors less experienced staff members; may provide guidance to and collaborates with other professionals.External: Interfaces with vendors, U.S. Food and Drug Administration (US FDA) inspectors and other agency representatives regarding regulatory issues as well as consultants. May also interact with physicians, scientists, and other researchers.Equipment: List the type of equipment the incumbent in this position is required to work with.Works with a personal computer, standard commercial and specialized software, and standard office equipment such as the telephone, fax machine, copier, etc. In addition, may work with various veterinary-type surgical and medical instruments, equipment (including both electrical and electronic), procedures and reagents.Working Conditions: Describe the work environment characteristics representative of those encountered by an employee performing the essential functions of this job.Works in a research laboratory that is in compliance with the US FDA Good Laboratory Practices (GLP). Good lighting. Quiet to moderate noise level. Minor amount of exposure to fumes or airborne particles and toxic/caustic chemicals. Exposure to possibility of electrical shocks. Works with sensitive precision equipment that requires special handling.Physical Demands: Describe the physical demands representative of those that must be met by an employee to successfully perform the essential functions of this job.Activities require a significant amount of sitting at a desk in front of a computer, also standing and walking through production areas. Requires ability to reach with arms and hands, manual dexterity, and good hand/eye coordination to use keyboard, telephone, write memos, etc. Ability and necessity to lift and carry relatively light objects is negligible. Meetings and discussions require significant use of voice and hearing. Clear vision (correctable) and good color vision is also required to perform job functions.Required: Bachelors Degree in the Sciences (e.g. Biology), Technology, a related field, or equivalent. Demonstrated knowledge of Good Laboratory Practices (GLP) standards and animal health requirements. Demonstrated working knowledge of animal handling, animal surgery and operating room techniques is also required. Work requires knowledge of applicable U.S. Food & Drug Administration (FDA) regulations as well as related domestic and international quality system audit requirements, and the necessity of working within those constraints. Must have demonstrated written and verbal communication skills (i.e. English grammar and style), interpersonal, presentation, analytical, organizational skills, the ability to interpret basic clinical data, and the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must have demonstrated basic personal computer skills including a working familiarity with word processing software and relevant regulatory applications. The ability to concentrate on detail and work independently when necessary.Desired: An advanced credential in a relevant discipline/concentration. Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP) certification is preferable. Ideally a minimum of eight plus years of progressively more responsible animal care experience. Quality assurance work experience in auditing in a medical devices company.An Equal Opportunity EmployerAbbot welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

Keywords: Abbott, Fresno , Quality Audit Specialist, Accounting, Auditing , Fresno, California

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