Associate I, Manufacturing

Position Summary

Responsible for performing processing/manufacturing activities of Human Transplant Tissues and devices in an FDA regulated GMP facility.

Essential Duties & Responsibilities
• Prepare processing solutions and storage media.
• Thaw and process frozen placental tissues into finished products.
• Perform production control on 100% of units manufactured, packaged and labeled.
• Initiate processing area set up and change over as needed.
• Conduct line clearance, equipment cleaning and facility cleaning as needed.
• Perform final product label creation, verification and labeling.
• Store final product in designated quarantine areas.
• Complete documentation (e.g. batch records, cleaning logs, etc.) for review.
• Maintain aseptic and/or neat work environments.
• Prepare disinfectant for equipment and Facility cleaning as necessary.
• Complete requisitions for quality control samples and submit to the designated lab for bio-burden testing.
• Provide information as needed to assist with investigations.
• Document/report equipment and facility problems and any potential deviation during processing.