Abbott Quality Audit Specialist in Sylmar, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The Quality Audit Specialist will work 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.
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 contractor’s 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.
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.
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.
Qualifications and Experience:
Bachelor’s Degree in the Sciences (e.g. Biology), Technology, a related field, or equivalent.
Demonstrated knowledge of Good Laboratory Practices (GLP) standards.
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.
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 responsibilities.
Quality assurance work experience in auditing in a medical devices company.
An Equal Opportunity Employer
Abbot 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 firstname.lastname@example.org