Position Summary :

The Tissue Processing Technician supports the processing and documentation requirements of tissue during the cleaning, cutting, shaping, inspecting, and packaging operations of donated birth tissue for transplantation purposes.

The Tissue Processing Technician is also responsible for ensuring that all equipment and supplies used for processing are maintained and ready for use while complying with Quality Assurance requirements as mandated by federal (FDA), state, and AATB regulations.

Essential Duties and Responsibilities :

• Include but are not limited to the following, other duties may be applied;
• Process perinatal tissues into allograft products in an ISO 5 environment.
• Responsible for completion of the daily documentation of tissue processing.
• Perform production control on 100% of units manufactured, packaged and labeled.
• Ensures that Processing Operations comply to State and Federal (FDA) Regulations and AATB Standards
• Initiate processing area set up and change over as needed.
• Perform equipment cleaning and facility cleaning as needed.
• Perform final product labeling and packaging.
• Maintain storage of final product in designated quarantine or released areas.
• Maintain aseptic and / or neat work environments.
• Perform steam sterilization of instruments.
• Perform environmental monitoring tasks.
• Prepare disinfectant for equipment and facility cleaning as necessary.
• Adhering to Standard Operating Procedures (SOPs)
• Adhereing to Good Documenation Practices (GDPs).
• Generate and investigate deviations, out of specification results, and change controls related to manufacturing equipment and processes.
• Complete requisitions for quality control samples for outside testing.
• Responsible for other duties and projects as assigned.

Qualifications :

• Candidate must know aseptic technique.
• Bachelor's Degree in science or related field or Associate degree with 1 or more years of relevant experience.
• Laboratory and / or cleanroom experience.
• Attention to detail with neat and legible handwriting.
• Experience in a GMP manufacturing environment.
• Ability to work independently and in a team.
• Multi-tasking in a fast-paced environment.
• Proficient in Microsoft Word, Excel and Outlook. Powerpoint is a plus.
• Must possess excellent communications skills, both oral and written
• Strong analytical, planning, critical thinking, and troubleshooting skills
• Ability to effectively communicate with multidisciplinary teams
• Well-developed interpersonal skills.
• Results oriented with a high level of initiative.

Certificates, Licenses, Registrations

CTBS Certification is desirable

Physical Demands

• Regularly required to sit for long periods of time.
• Lift and / or move up to 10 pounds and occasionally lift and / or move up to 40 pounds.

Work Environment and Environmental Conditions

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is typically moderate.
• The environment is primarily a production environment with some warehouse duties.
• There is some limited exposure to physical risk and blood borne pathogens.

PPE Requirements

• Eye protection required when working in the operations area.
• Foot apparel must cover all portions of the foot.

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Last updated : 2024-02-27