Job Overview Company: Smith Hanley Consulting Group Base Pay: N/A Other Pay: Employee Type: Contractor Industry: Biotechnology
Pharmaceutical Manages Others: Not Specified Job Type: Biotech
Pharmaceutical Required Education: 4 Year Degree Required Experience: 6 to 10 years Required Travel: Not Specified Relocation Covered: Not Specified Reference ID: 86775 Location: US-CA-Menlo Park Contact: Clinical Recruiters Phone: Not Available Email: Send Email Now Fax: Not Available Company Overview Our Commitment
We are committed to our relationships with our clients, candidates, and consultants, as well as to one another and our communities. We hope our dedication to these relationships shines through with the partnerships we nurture daily. To achieve success in all facets, we value trust, communication, customer service, and diversity.
We demonstrate our commitment to diversity by recruiting from all backgrounds, cultures, and ethnicities. We recognize the unique differences each employee brings to the company and we support environments that encourage diversity, believing that it adds value to the organization. This value is evident in every aspect of the organization: new ideas and perspectives, motivation, buy-in, retention, and new sources of talent. By valuing differences, we affirm our dedication to treating everyone with fairness and respect. Learn More about Smith Hanley Consulting Group
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Job Description
Position Overview:
Audits areas of the company Vascular quality system, such as development and manufacturing, as assigned Creates audit checklists based on assigned area, applicable regulations, and pertinent company Vascular quality system/procedural requirements, and obtains approval from Lead Auditor as appropriate. Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation Formulates and documents nonconformity and obtains concurrence with responsible management. Tracks issues through to closure including reviewing the corrective action taken. Develops an audit plan including scope and objective and obtains management approval. Provides work direction to audit team. Communicates final results of audits to responsible management during formal management debriefs.; Writes reports of audit results, obtains approval, and publishes results to responsible management. Oversees follow-up of corrective actions and audit closure, including escalating overdue items as necessary Serves as escort to inspectors or assessors from regulatory agencies or notified bodies. Provides input to Regulatory Compliance Manager on audit staff performance. As requested, coordinates product actions (for example recalls) with manufacturing units and affiliates. As requested, communicates product actions and subsequent updates to regulatory bodies Serves as quality system expert resource to management and to other business units as requested.; Presents results of audits to senior management such as during periodic quality system reviews. Serves as point-of-contact for regulatory agency inspections or assessments Works with Regulatory Compliance Manager to develop the annual audit schedule, assignments, and budgetary impact. Provides input to Regulatory Compliance Manager regarding Lead Auditor performance.
Job Requirements
Required Qualifications:
Bachelor's degree plus 6
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