Production Quality Control Technician I

About the Role

The Operations Production Quality Control Technician I reviews and inspects documentation requirements of tissue during all steps of processing of Musculoskeletal tissue and Birth tissue. This role also reviews documentation for the cleaning of processing rooms and the sterilization of goods used in the production of allografts. The Technician verifies documentation against electronic records, uploads Tissue batch and labeling batch records into electronic form, and archives documentation in compliance with Quality Assurance requirements as mandated by federal, state, and trade regulations.

Responsibilities

• Reviews for correction and completeness of all batch records generated during the production of allografts and Autografts.
• Reviews for correction and completeness all data entry and corresponding spreadsheets generated in the production of allografts and Autografts.
• Coordinates for a timely review and correction of all generated product batches prior to submission to QA for final review and disposition.
• Responsible for entry and maintenance of Batch record Spreadsheet and Labeling batch Spreadsheet.
• Reviews and archives VRL accession culture documentation, and responds to or properly directs requests for clarification and nonconformance of testing requests.
• Responsible for issuing and verifying FM GEN 2 (Electronic Signature Acknowledgement form) for Processing personnel.
• Reviews and catalogs all logs generated in the cleaning of Production clean rooms.
• Reviews and catalogs all logs generated in the sterilization of sterilized goods used in the production of allografts.
• Reviews and uploads Tissue Receipt Forms.
• Ensures that Processing Documentation complies with State and Federal Regulations and AATB Standards.
• Works under a challenging sense of urgency for customer delivery and Quality Standards during Document Review, uploading, and archiving.
• Uses judgment to identify, troubleshoot, and resolve day-to-day Production Quality Control flow interrupters.
• Completes the daily review of documentation of tissue Processing.
• Performs other duties as assigned on an as-needed or emergency basis.

Requirements

• Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension.
• Bachelor’s degree in science or related field with a minimum of 0-1 year of relevant experience, or an associate degree with 1 or more years of relevant experience (preferred).
• Tissue Banking experience preferred.
• Strong analytical, planning, critical thinking, and troubleshooting skills.
• Ability to effectively communicate with multidisciplinary teams.

Skills

• Computer Processing
• Problem Solving
• Strong Interpersonal and organizational skills
• Good documentation skills
• Written, verbal, and strong communication skills
• Attention to detail

Working Conditions

• Majority of the work is performed indoors in an office environment.
• Ability to sit for extended periods of time.
• Regular lifting/carrying of light objects up to 10 pounds.

No direct reports.