QA/QC Coordinator- Biotechnology

Overview

Surgenex® is a leading biotechnology firm dedicated to the development and commercialization of high-quality placental tissue and musculoskeletal implants. Our commitment to stringent quality and safety standards ensures that we deliver innovative solutions while exceeding customer expectations. The role is vital in maintaining our high standards of quality and compliance, ensuring that our products meet both industry regulations and customer needs.

Position Summary

The Quality Assurance (QA) / Control (QC) Coordinator is responsible for ensuring all aspects of the quality assurance and control functions of the department are cohesive and efficient. The QA/QC Coordinators are responsible for ensuring alignment to Surgenex policies, applicable regulations, and standards; while strives to provide quality, safety, and integrity to human tissues processed and distributed by Surgenex.

Essential Functions

• The QA/QC Coordinator is responsible for ensuring he/she is trained and competent to perform quality functions such as donor eligibility chart review, label generation, batch record review, tissue irradiation, and real time quality product control.
• Learn QA and QC procedures and best practices.
• Effectively communicates to the QA/QC Manager regarding job responsibilities, time management, workflow, and communication.
• QA/QC are responsible for ensuring adequate inventory for supplies used during final labeling and packaging.
• Ensures the traceability throughout the labeling process and ensures lot clearance procedures are followed and maintained.
• The QA/QC will be responsible for ensuring irradiation shipments of HCT/Ps, both the preparation and receipt of these shipments
• 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.
• 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 to determine donor eligibility.
• Receives, compiles, and reviews donor cultures and serologic results. Documents and alerts appropriate staff for results that would contraindicate donation based on eligibility criteria including any delays in final reporting.
• 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 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.
• 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.

Skills & Abilities

• 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.
• Adaptability - Ability to adapt to change in the workplace.
• Analytical Skills - Ability to use thinking and reasoning to solve problems.
• Compliance - Ability of the individual to be in accordance with established guidelines, policy, standards, or legislation.
• Communication - Ability to communicate clearly and concisely.
• 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.
• Diversity Oriented - Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.
• Ethical - Ability to demonstrate conduct conforming to a set of values and accepted standards.
• Honesty/Integrity - Ability to be truthful and be seen as credible in the workplace.
• Independence - Ability to work independently with minimal supervision.
• Judgment - Ability to formulate a sound decision using the available information.
• Organized - Possessing the trait of being organized or following a systematic method of performing a task.
• Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
• Responsible - Ability to be held accountable or answerable for one’s conduct.
• Technical Aptitude- Ability to comprehend complex technical topics and specialized information.
• Time Management - Ability to utilize time efficiently and meet deadlines.

Position Qualifications

Education: Bachelor’s Degree in a relevant scientific field; biology, biotechnology, medical technology, etc. Equivalent work experience may be substituted for education.

Experience: Tissue banking or related healthcare or biotechnology industry.

Computer Skills: Proficient with Macintosh/Apple and Google computer systems and applications.

Certificates &* Licenses*: None, AATB – CTBS preferred

Other Requirements: None

If you are passionate about ensuring product excellence in the biotechnology field, we invite you to apply for the Quality Assurance Coordinator position at Surgenex. Join us in making a difference!

Job Type: Full-time

Pay: $52,000.00 - $70,400.00 per year

Benefits:

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

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Night shift
• Weekends as needed

Education:

• Bachelor's (Required)

Location:

• Scottsdale, AZ 85260 (Required)

Shift availability:

• Day Shift (Required)
• Night Shift (Required)

Ability to Commute:

• Scottsdale, AZ 85260 (Required)

Ability to Relocate:

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

Work Location: In person

Salary : $52,000 - $70,400