Operations Processing Technician I
VIVEX BIOLOGICS INC
Job Description
Job Description
Description:
Job Purpose
The Operations Processing Technician I support the processing and documentation requirements of tissue during the cleaning, cutting, shaping, inspecting, and packaging operations for transplantation purposes. The Operations Processing Technician I is also responsible for ensuring that all equipment and supplies used for processing are maintained and ready for use, and that all Processing Room maintenance is completed daily while complying with Quality Assurance requirements as mandated by federal, state, and trade regulations.
Duties and Responsibilities
- Promotes Lean behaviors across the organization (includes leading and participating in Try storming, Brainstorming and other Lean related initiatives)
- Preparation of aseptic processing, environmental set-up including all equipment supplies and monitoring of sterile rooms as per SOP requirements.
- Processing of all allografts for clinical use such as bone, soft tissues, skin, autografts and other tissues as instructed by Processing Supervisor, Team Lead or designee.
- Daily activities include:
- Preparation and preservation of all types of bone, soft tissue, and birth tissue for cutting and shaping into allografts.
- Lyophilization
- Treatment of tissue with liquid nitrogen when applicable
- Tissue allograft
- Culture sampling and packaging as specified by SOPs.
- Decalcification of bone as applicable per SOPs.
5. Familiarity and knowledge of information contained in the Tissue Bank Manuals.
6. Applies Problem Solving Techniques and 5 WHY’s analysis to address Non-Conformities, Correction reports, and Customer Complaints as well as Technical Challenges by means of applying the root cause analysis process.
7. Ensures that Processing Operations comply to State and Federal Regulations and AATB Standards.
8. Driven by a challenging sense of urgency for customer delivery and Quality Standards during Processing.
9. Coordinates with Supporting Teams During the Process of Product Transfer for Execution of pilot runs at the Processing Stage.
10. Uses Judgment to Identify, Troubleshoot and resolve Day-to-Day Technical Operations Flow interrupters.
Requirements: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.
Qualifications include:
- Computer Processing
- Lean Behaviors
- 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 and in a cleanroom environment. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary.
Physical Requirements
The ability to stand for extended periods of time. Occasional lifting/pushing heavy objects up to 50 pounds.
Direct Reports
No Direct Reports.
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