Production Quality Control Technician I

VIVEX Biologics, Inc.; Miami, Northern (FL, KY); Hybrid; USD 45,000 - 65,000; Full time

Job summary

VIVEX Biologics, Inc. seeks an Operations Production Quality Control Technician I to review batch records, ensure data accuracy, and archive documentation in accordance with QA standards.

You will verify electronic records, support room cleaning and sterilization documentation, and collaborate with cross-functional teams to maintain quality during tissue processing. The role requires a science degree with 0–1 year relevant experience and strong analytical, communication, and problem-solving

Qualifications

• 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.
• Tissue Banking experience Preferred.
• Strong analytical, planning critical thinking, and troubleshooting skills.
• Ability to effectively communicate with multidisciplinary teams.

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

Skills

Tissue Banking

Analytical skills

Troubleshooting

Communication skills

Documentation

Attention to detail

Team collaboration

Problem Solving

Interpersonal skills

Organizational skills

Education

Bachelor’s degree in science or related

Associate degree + 1+ years experience

Job description

Description

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. Please note this is not an offer of immigration sponsorshipDuties and Responsibilities

1. Reviews for correction and completeness of all batch records generated during the production of allografts and Autografts.

2. Reviews for correction and completeness all data entry and corresponding spreadsheets generated in the production of allografts and Autografts.

3. Coordinates for a timely review and correction of all generated product batches prior to submission to QA for final review and disposition.

4. Responsible for entry and maintenance of Batch record Spreadsheet and Labeling batch Spreadsheet

5. 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.

6. Responsible for issuing and verifying FM GEN 2 (Electronic Signature Acknowledgement form) for Processing personnel.

7. Reviews and catalogs all logs generated in the cleaning of Production clean rooms

8. Reviews and catalogs all logs generated in the sterilization of sterilized goods used in the production of allografts.

9. Reviews and uploads Tissue Receipt Forms.

10. Ensures that Processing Documentation comply to State and Federal Regulations and AATB Standards.

11. Understands and able to work under a challenging sense of urgency for customer delivery and Quality Standards during Document Review, uploading and archiving.

12. Uses Judgment to identify, troubleshoot and resolve day-to-day Production Quality Control flow interrupters.

13. Resourceful in completing assigned deadlines and can multitask effectively.

14. Responsible for completion of the daily review of documentation of tissue Processing.

15. Perform other duties as assigned on an as needed or emergency basis, and as assigned by Manager or Supervisor

Qualifications

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. Strong analytical, planning critical thinking, and troubleshooting skills. Ability to effectively communicate with multidisciplinary teams.

Qualifications include:

• 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.

Physical Requirements

The ability to Sit for extended periods of time. Regular lifting/carrying light objects up to 10 pounds.

Direct Reports

No Direct Reports.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.

VIVEX Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

VIVEX Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.