Biomedical Lab Technician

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 the completion of the daily documentation of tissue processing.
• Perform production control on 100% of units manufactured, packaged, and labeled.
• Ensures that Processing Operations comply with State and Federal (FDA) Regulations and AATB Standards
• Initiate processing area setup 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)
• Adhering to Good Documentation 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 the 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 communication 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