Quality Auditor/specialist - Scottsdale, United States - Surgenex

Surgenex

Verified Company

Scottsdale, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Job description

About Us:
SURGENEX is a privately held biotechnology company and accredited Tissue Bank by the AATB. Our company is headquartered in Scottsdale, Arizona. We develop, manufacture, and distribute the highest quality tissue allograft in the industry to accounts within the United States.

***This position is responsible for monitoring and analyzing current and impending regulations and standards,conducting, and facilitating internal and external audits. The Quality Specialist (QS) will assist with the development and implementation of Corrective and Preventive action (CAPA) plans and conducting Verification of Effectiveness (VOE) Checks. Assists with ensuring compliance to state, federal, local, international, and accrediting agency regulations and standards as well as Surgenex standard operating procedures (SOPs). This position is also responsible for technical development of personnel, leading others through audits, ensuring audit deliverables, and maintaining the quality management system documentation.

KEY RESPONSIBILITIES

Execute and monitor all Surgenex processes and activities to ensure compliance and product quality.
Participate in the creation, implementation, and monitoring of processes to ensure product specifications are met.
Responsible for conducting internal audits per the established audit schedule to ensure Surgenex's compliance to all Surgenex procedures, federal, state, local and international regulations and accrediting agency standards and assisting with conducting and facilitating external audits.
Identify processes for audit, to include:
those required by regulatory bodies or accrediting agencies.

- processes having undergone significant revision.
- effectiveness assessments of corrective and preventive action plans.
- those processes with a significant number of failure points.

Surgenex regulatory and accrediting agency audit CAPA responses.
Observe, review, and analyze processes to ensure quality standards are upheld throughout the organization at all times.
Ensures audits (selfassessments) required by accrediting bodies are completed within prescribed time frames.
Conducts audits in accordance to established SOPs ensuring:
Audits are scheduled, conducted, and documented within the quality management system audit program including the initiation of a nonconformance report (NCR) for all audit findings.
Use of audit assessment checklists which will assess compliance of written policy against regulation and current practice against written procedures.
Audit reports are written and provided to Surgenex Leadership
Timely receipt and closure of NCR/CAPA responses
Verification of effectiveness is performed to ensure ongoing compliance with the implemented CAPAs
Serves as a resource for the development of corrective actions to address observations and findings.
Assist the DRA with preparing for and facilitating external audits in accordance to established procedures.
Audits are initiated, conducted, and documented within the quality management system audit program including the initiation of NCR's for all audit findings.
Assist with the development and completion of regulatory and accrediting agency gap assessment tools
Meet with respective department management and staff to collaboratively complete gap assessments
Assist with addressing all gaps identified to ensure Surgenex establishes compliance
Responsible for monitoring and analyzing changes in regulatory and accreditation standards that impact operations including but not limited to those of FDA and AATB.
Qualify and monitor suppliers and service providers.
Will recommend actions for vendors or suppliers that do not maintain compliance requirements or have a high complaint and/or NCR rate.
Responsible for assisting the DRA with maintaining the supplier program in the quality management system, ensuring all vendors are documented, accurately categorized, and all relevant documentation (qualification surveys, licenses, registrations, etc.) is attached.
Track and trend audit findings to assist departmental management in identifying opportunities for improvement (OFIs).
Serve as a resource to departmental management in reviewing proposed revisions to policies, procedures, and forms to determine regulatory compliance prior to implementation.
Performs other duties as assigned.