Production Quality Control Technician I
About The Position
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. The Production Quality Control Technician I also reviews documentation for the cleaning of processing rooms and documentation for the sterilization of goods used in the production of allografts. The Production Quality Control Technician I will also verify documentation against electronic records and upload Tissue batch and labeling batch records into electronic form. The Production Quality Control Technician I will also archive documentation complying with Quality Assurance requirements as mandated by federal, state, and trade regulations.
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.
- Computer Processing
- Problem Solving
- Strong Interpersonal and organizational skills
- Good documentation skills
- Written, Verbal and strong communication skills
- Attention to detail
Nice To Haves
- Bachelor’s degree in science or related with a minimum of 0-1-year relevant experience or associate degree with 1 or more years of relevant experience, preferred.
- Tissue Banking experience Preferred.
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.
- Responsible for review and archiving of VRL accession culture documentation as well as, responding to or properly directing request for clarification and nonconformance of testing request.
- 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 comply to State and Federal Regulations and AATB Standards.
- Understands and able to work 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.
- Resourceful in completing assigned deadlines and can multitask effectively.
- Responsible for completion of the daily review of documentation of tissue Processing.
- Perform other duties as assigned on an as needed or emergency basis, and as assigned by Manager or Supervisor.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
