SURGENEX® is a privately held biotechnology company. 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.

Job Description:

The Quality Product Coordinator (QPC) is responsible for assisting with safeguarding the quality, safety, and integrity of human tissues processed and stored within Surgenex. This position supports development and execution of comprehensive quality control measures, monitoring tissue processing, conducting tests, and ensuring strict compliance with regulatory standards ensuring tissues meet quality standards for transplantation and research purposes.

ESSENTIAL FUNCTIONS

• Assist with developing and implementing quality control procedures, including real time processing QC for human tissue processing.
• Provide hands-on oversight of tissue processing activities, ensuring that protocols are strictly followed and parameters such as temperature, humidity, and processing times are maintained within specified ranges.
• Support the Regulatory department with accessing the compliance of processing and address any potential opportunities for improvement and correction.
• Conduct QA reviews of batch records, donor records and any other associated documentation to ensure accuracy, completeness, and compliance.
• Assist with the tissue final release process including but not limited to final labeling and packaging.
• Stay updated on regulatory requirements for tissue banking, including state, local, federal and international regulations, and accrediting agency standards.
• In collaboration with the Director of Quality Assurance, develop metrics, analyze quality control data and prepare reports to identify trends and opportunities for improvement.
• Actively participate in and contribute to continuous improvement initiatives within Surgenex.
• Propose and implement enhancements to quality control processes for enhancement of efficiency and effectiveness.
• Perform product inspection to ensure quality standards are met and re-work, if needed, can be performed real time.
• Investigate and document any non-conformances related to the tissue quality, Surgenex procedures and regulatory gaps identified and collaboratively develop effective corrective and preventive actions.
• Train and educate tissue bank staff on quality control procedures and best practices.
• Ensure staff compliance with quality management system procedures.
• Other duties as assigned.

POSITION QUALIFICATIONS

Accuracy

• Ability to perform work accurately and thoroughly.

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 a relevant scientific field (biology, biochemistry, etc.). Equivalent work experience may be substituted for education.

Experience:

• Tissue banking or related healthcare or biotechnology industry.

Computer Skills:

• Proficient with Microsoft office suite

Shift: 1st Shift (6am-3pm) Weekends Required

Job Type: Full-time

Pay: $48,400.00 - $52,800.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Weekends as needed

Work setting:

• In-person
• Manufacturing facility

Ability to Relocate:

• Scottsdale, AZ 85260: Relocate before starting work (Required)

Work Location: In person