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.
POSITION SUMMARY Job Status: Full- Time.
Reports To: Chief Quality and Regulatory Officer Positions Supervised: None
This position is responsible for monitoring and analyzing current and impending regulations and standards, conducting, and facilitating internal and external audits.
The Quality Audit Specialist (QAS) will assist with the development and implementation of Corrective 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 always upheld throughout the organization. Ensures audits (self-assessments) required by accrediting bodies are completed within prescribed time frames.
Conducts audits within the e-QMS, QT9, in accordance with established SOPs ensuring: Audits are scheduled, conducted, and documented within the quality management system audit program including the initiation of a corrective action report in QT9 for all audit findings.
Use of audit assessment checklists which will assess compliance of written policy against regulation and current practice against written procedures. o Audit reports are documented in QT9 and provided to Surgenex Leadership to timely receipt and closure of CAPA responses Verification of effectiveness is performed to ensure ongoing compliance with the implemented CAPAs to Provide statistical reports based on the tracking and trending of Audit Findings for trending analysis.
Serves as a resource for the development of corrective actions to address observations and findings. Assist the CQRO with preparing for and facilitating external audits in accordance with established procedures. Audits are initiated, conducted, and documented within the quality management system audit program including the initiation of occurrences for all audit findings. Assist with the development and completion of regulatory and accrediting agency gap assessment tools to Meet with respective department management and staff to collaboratively complete gap assessments to 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 occurrence rate. Responsible for assisting the QDRA 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.
Maintains all existing licensure or registrations ensuring they are current. Assists the CQRO with new applications for licensure or registration including and not limited to the completion of re- accreditation applications and pre-inspection checklists. Track and trend audit findings to assist departmental management in identifying Opportunities for Improvement (OFls).
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
Required Skills & Qualifications Accuracy -
Ability to perform work accurately and thoroughly.
Accountability- Ability to accept responsibility and account for his/her actions. Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
Conflict Resolution - Ability to deal with others in an antagonistic situation. Customer Oriented - Ability to take care of the customers' needs while following company procedures.
Detail Oriented - Ability to pay attention to the minute details of a project or task. Honesty/
Integrity - Ability to be truthful and be seen as credible in the workplace. Organized - Possessing the trait of being organized or following a systematic method of performing a task.
Responsible - Ability to be held accountable or answerable for one's conduct. Self-
Confident - The trait of being comfortable in making decisions for oneself. Time Management - Ability to utilize the available time to organize and complete work within given deadlines.
Communication - Ability to communicate effectively with others.
Adaptability - Ability to adapt to change in the workplace. Diversity Oriented - Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.
Compliance - Ability of the individual to be in accordance with established guidelines, policy, standards, or legislation.
Computer Skills - Proficient with Microso Office Suite, knowledge of Quality Management Soware preferred. Certificates & Licenses - ASQ certification - Certified Quality Auditor (CQA) must be obtained within 18 months of employment; CTBS Certification desirable.
Education & Experience Educa on: High School Diploma, Bachelor's Degree in Physical Sciences or Quality Studies preferred.
Experience: Minimum of 3 years of progressive experience in ssue banking, pharmaceutical, manufacturing or healthcare auditing.
Physical Demands & Work Environment This position requires prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times. The role operates in a professional office environment with moderate noise levels.
Hours are M - F 6am - 3pm
Job Type: Full-time
Pay: $65,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience:
- Manufacturing: 1 year (Preferred)
Shift availability:
Ability to Commute:
- Scottsdale, AZ 85260 (Required)
Ability to Relocate:
- Scottsdale, AZ 85260: Relocate before starting work (Required)
Work Location: In person
