QAC III (Tissue Recovery)

Company Overview

Surgenex® is an industry-leading biotechnology firm dedicated to developing and commercializing high-quality placental tissue and musculoskeletal implants. Our commitment to safety and quality is reflected in our comprehensive processing capabilities and our focus on delivering exceptional customer service.

Summary

The Quality Assurance Coordinator III (QAC III) supports Surgenex's mission by providing regulatory support. The QAC III supports the Quality Assurance/Quality Control Department with performing cadaveric and birth tissue donor chart QA in compliance with FDA regulations, AATB standards, and Surgenex’s policies and procedures. This position is responsible for supporting the quality assurance work of the company by performing birth tissue donor chart quality assurance in accordance to Surgenex policy and procedures. Requests for additional donor information are documented on partner pending logs, and final compilation and review of relevant donor records are performed prior to submitting to the Medical Director to determine donor eligibility.

Responsibilities

• Receives, compiles, and reviews cadaveric and birth tissue donor records ensuring initial minimal required documentation is received from recovery/acquisition agencies to ensure adequate and relevant donor information is received to perform chart quality assurance for Medical Director donor eligibility determination.

• Maintains positive communication with tissue recovery/acquisition partners. Sends information / documentation requests via the processor pending logs to the recovery/acquisition agencies. May provide final disposition for tissue donors.

• Provides initial, periodic and re-training of quality documentation for birth tissue donor related activities for quality, acquisition, and processing staff.

• Responsible for collaborating with the Finance department to reconcile billing and accounts receivable information against the QA pending charts, the electronic donor medical record, and recovery/acquisition pending logs.

• Assist Quality & Regulatory Affairs with performing quality audits including but not limited to donor consents and uniform donor risk assessment interviews to ensure compliance with Federal, State, International Regulations and accreditation standards, and Surgenex’s policies and procedures.

• Supports and participates in scheduled and unscheduled tissue partners, regulatory and accrediting agency audits including but not limited to the FDA and AATB.

• Monitors and maintains the current status of donor records using established electronic tracking systems, obtaining additional information as necessary.

• Responsible for supporting the use of systems within Surgenex’s Quality Management System and improvement initiatives within the Quality & Regulatory Affairs Department.

• Assists with initiating and conducting investigations and follow-up for reported adverse reactions and complaints. Responsible for ensuring all reports are adequately closed and warranted corrective actions are completed.

• Recognizes and reports trends and opportunities for improvement (OFI) regarding donor records, Quality & Regulatory Affairs and organizational metrics to the Sr. Director and Manager of Quality Assurance / Quality Control, or designee.

• Other duties as assigned.

• Effectively communicates with the Medical Director(s) to seek guidance for medical and donor record questions. Sends donor records for donor eligibility determination.

• Facilitates requests from recovery/acquisition partners for but not limited to medical record documentation, autopsy reports, death certificates, EMS reports, MARs, serology reports and other information for donor eligibility in accordance with regulatory and accreditation entity requirements as well as Surgenex’s policy and procedure. Ensures verification of information is performed.

• Ensures timely receipt of documentation from partners. Reports to outside agencies and partners and affected Surgenex staff relevant information, including but not limited to, positive serology reports and positive culture reports.

• The QAC III will be responsible for assisting in employee training and development.

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.
• Team Builder - Ability to convince a group of people to work toward a goal.
• Communication, Oral - Ability to communicate effectively with others using the spoken word.
• Communication, Written - Ability to communicate in writing clearly and concisely.
• Accountability - Ability to accept responsibility and account for his/her actions.
• Judgment - The ability to formulate a sound decision using the available information.
• 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.

If you are ready to make a significant impact in the biotechnology field and possess the skills needed for excellence in tissue recovery, we invite you to apply today at Surgenex!

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year

Benefits:

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

Schedule:

• 8 hour shift

Work Location: In person

Salary : $50,000 - $60,000