Internal Auditor: ATR International, Inc.

ATR Professional, a division of ATR International, has been a leader in the staffing industry since 1988, placing professionals in the industry's most innovative companies. We currently have an exciting opportunity for an Internal Auditor with one of our important clients.

Position Information:
Job Title: Internal Auditor
Location: Alameda , CA
Duration: Indefinite
Compensation: Open$/hour

Job description:

We are looking for someone who will work to progress Investigations, ERs, and CAPAs support the Sustaining Engineering Team. Ensure actions are on time, in full and cost effective to meet the needs of the business and customers, and that they support core values of the division. To ensure that ERs, CAPAs, and investigations meet required standards / procedural requirements. To be an effective member of a multifunctional team. Ensure that all communications, interpersonal interactions and business behaviors are consistent with the company's Code of Conduct. Support the development of cost efficient business processes whilst ensuring compliance and quality requirements are met. 3-5 years experience.

The Staff Auditor is responsible for the implementation of audits required for compliance with Regulatory standards and leads improvement activities within the Quality System department. Duties related to audit program include: internal/clinical trials/supplier audit function planning, developing audit schedules and plans, performing and documenting audits and managing all related following up activities. The Staff Auditor will work well with staff, colleagues and peers, and continually strive to improve the actions/quality of the internal audit program. The Staff auditor will act as a mentor to auditors/lead auditors and clinical research associates (CRA), supporting the development, training and supervision of these employees. The Staff Auditor will provide support to the Audit Manager, by facilitating external audits, identifying and leading process improvements changes. Responsible for implementing and maintaining the effectiveness of the Quality System Leads in internal and external audit program in accordance with Corporate and Divisional standards in order to assure that Quality Systems and controls (including performance metrics and analysis) are appropriate and maintained. Such standards include FDA QSR, ICH, GCP, ISO 13485 and 14971, PAL, CMDR, MDD and IVDD. Ensures that process and procedures related to Internal Auditing are followed and adhered to. Conducts Clinical trial audits and performs any related follow-up activities Conducts Supplier audits and performs any related follow-up activities Facilitates external audits as performed by Corporate or Regulatory agencies Identifies and generates process and program metrics in collaboration with site and divisional requirements Able to deputize for Audit Manager, as requested. and provide support in areas of staff supervision, trainingd clinical trial staff, as necessary.

Requirements:

The ideal candidate must demonstrate excellent interpersonal skills when dealing with internal & external customers under stressful circumstances; demonstrate the ability to identify, analyze & report opportunities for improvements & contribute to solutions; demonstrate creativity & flexibility in defining alternative solutions when problem solving; demonstrate fact based decision making skills (derived from objective evidence; effectively communicated) Bachelors Degree in Medical Technology, Chemistry, Biology, or another scientific discipline. Certified Quality Auditor (ASQ) or Certified Lead Auditor (RAB recognized organization). Clinical Trial certification (CCRA or CCRC preferred) or experience of Clinical Trial auditing/operational experience is required. Extensive knowledge of regulations & st&ards affecting IVDs, Biologics & Clinical trials (FDA QSR, ICH, GCP, ISO 13485 & 14971, PAL, CMDR, MDD & IVDD). 5-8 years QA &/or RA experience in a medical device quality system including extensive experience conducting internal & external audits according to the guidelines described in ISO 19011. 3-5 years experience of Clinical Trial auditing/operational environment. 3 years in management or lead auditing experience. Excellent writing, communication, objectivity & interpersonal skills, especially in stressful circumstances. Strong team building & decision making skills Strong ability to identify, analyze, & report opportunities for improvements & lead to successful implementation of solutions. Proficiency with software applications such as MS Word, Excel, Access, Visio, IBM Lotus Notes & be able to maintain simple databases for the purpose of tracking/trending audit findings. Experience with training & mentoring of auditors, CRAs. Inability to complete or effectively implement internal & clinical trial audit programs will have a negative regulatory impact on the org.

To be considered for this position, please click the "Apply Now" button or contact the following recruiter directly:

Name: “CD” Cuong Dang
Phone: 408.328.8059
Email: cuongd@atr1.com

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