100,000's of Government Jobs

Search Government Jobs

Job Field: Legal Jobs
Location: Alameda, CA
Salary: $Not stated

JOB SUMMARY:

---

</tr>
<tr><td valign="top" width="450"><b>Audit, Support SpecialistAutoReqId 120367BRJob Family Quality AssuranceJob Category Full-TimeJob Classification Experienced/EstablishedDivision Abbott Diabetes CareShift FirstRelocation Assistance NoneOverview Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.Job Description PRIMARY JOB FUNCTION:The primary function of the Audit Support Specialist is to help manage the external audit process. Acts as a team member to complete assigned site audit / compliance projects including all interrelated activities. Identifies and elevates critical issues. Participates in compliance initiatives and product / process improvements. Support the compliance group in developing and maintaining standard audit processes to ensure compliance with local, divisional and corporate procedures, as well as conforming to the Quality Systems Regulations (21CFR 820), ISO 13485:2003 and other applicable regulations and standards.CORE JOB RESPONSIBILITIES:1. ADC Audit Readiness key contributor: a. Assists site compliance across the sites in planning and preparing for external audits b. Maintains documentation related to external audit activities, e.g. regulatory body reports, letters, certificates. c. Tracks External commitments. Prepares updates and maintains documentation for external auditing bodies d. Acts as secondary lead in audit ready room and ensures all activities are on track.2. External Regulatory Observation assessment across site: a. Assists management in monitoring and reporting AQR/FDA/Notified Body observations. b. Assists management in development of an effective system for aligning and integrating information from external audits. c. Assist functional areas with assessing and integrating changes in processes and procedures to align with corporate requirements d. Provides assistance and follow-up to the auditee to meet timeliness of audit closure.3. Ensures correct data and information is collected for management reviews; reviews and analyzes metrics data; reports conclusions and makes recommendations; provides reports in a timely manner. Includes the review of recent audit activity, analysis of data, preparation of the presentation and follow up on action items.4. Assist in the monitoring of ERs and CAPAs for the Quality Systems function as it relates to external audits. 5. Measures and reports progress against quality goals.Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by managementNote: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.POSITION ACCOUNTABILITY / SCOPE:The individual in this position is responsible for audit observation issue resolution and corrective action approvals. This position is accountable for the preparation and reporting of Quality related documentation. Failure to do so would negatively impact the business by inaccurately reporting information required for Management Quality decisions Comments (Optional): Self starter who can work independently or as part of a cross functional team. Adaptable and flexible to changing job demands.Skills/Experience Requirements Basic Qualifications:3-5 years in a Corporate environment in a support capacity. Project management and/or data analysis experience preferred. Knowledge of regulations and standards affecting In Vitro Diagnostics and Medical Devices (CFR 820) (e.g. ISO, FDA Quality System Regulations preferred. Candidates will have experience utilizing basic negotiation, influencing and conflict management skills, will interact effectively with peers and leadership across dep

KEY REQUIREMENTS:

---

Not stated