Salary will be based off of experience within field
4 Year Degree
Employer will assist with relocation costs.
Internal Number: 1116
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.
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 (self-assessments) 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.
Maintains all existing licensure or registrations ensuring they are current.Assists the DRA 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 (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.
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.
Education: Bachelor's Degree in physical sciences or quality studies is required.
Experience: Minimum of 3 years of progressive experience in tissue banking, pharmaceutical, manufacturing or healthcare auditing.
Computer Skills: Proficient with Microsoft office suite. Knowledge of quality management software preferred.
Certificates & Licenses: ASQ certification; Certified Quality Auditor (CQA) and CTBS Certification preferred and must be obtained within 18 months of employment.
Surgenex is a biotechnology company that specializes in the development and production of regenerative medicine products. They focus on using advanced technologies to harness the therapeutic potential of human tissue-derived materials.
Surgenex is known for its flagship product called Umbilical Cord Matrix (UCM) and Umbilical Cord Blood (UCB) products. These products are derived from donated umbilical cord tissue and blood collected during the birth of healthy, full-term babies. The company utilizes a proprietary processing method to obtain mesenchymal stem cells, growth factors, cytokines, and other biologically active components from these tissue sources.
The regenerative medicine products developed by Surgenex are used for various medical purposes, including wound healing, pain management, orthopedic applications, and tissue regeneration. They are often used in conjunction with other medical interventions to support the body's natural healing processes.