Associate I, Manufacturing

BioTissue Ocular; Miami (FL); Presencial; USD 42.000 - 60.000; Jornada completa

Descripción de la vacante

BioTissue Ocular is seeking a Processing Technician to perform manufacturing activities of human tissue products in an FDA-regulated GMP facility in Florida. Responsibilities include preparing solutions, thawing and processing placental tissues, maintaining clean rooms, handling labeling, and ensuring accurate batch records and quality control testing.

Ideal candidates will have a High School Diploma and 6 months biotechnical or GMP manufacturing experience, with familiarity in MS Office and

Formación

• Excellent communication skills; fluent (oral/written) English.
• Ability to multi-task and set priorities in a fast-paced environment.
• Proficient in Microsoft Excel, Word, PowerPoint and Outlook.
• Familiarity with GMP and bio-tissue banking standards.

Responsabilidades

• 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 setup 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 for batch records and logs.
• Maintain aseptic and neat work environments.
• Prepare disinfectants for equipment and facility cleaning.
• Submit QC samples for bio-burden testing.
• Assist with investigations and report findings.
• Document/report equipment and facility problems and deviations.

Conocimientos

Communication

Multi-tasking

Microsoft Office

GMP familiarity

Educación

High School Diploma

Associate’s Degree in Biotechnology / Life Sciences

Herramientas

Excel

Word

PowerPoint

Outlook

Descripción del empleo

Position Summary

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

• 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.

Skills & Abilities

Essential Duty Definition:

• Excellent communication skills; fluent (oral/written) English.
• Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional environment
• Communicates effectively and appropriately. Uses good judgment as to what to communicate to whom as well as the best way to get that accomplished. Speaks in a clear and credible manner, selecting the right tone for the situation and audience. Listens to others and allows them to make their point.
• Proficient in Microsoft software applications: Excel, Word, PowerPoint and Outlook.
• Familiarity with American Association of Tissue Banks, Good Manufacturing Practices (GMP), and Hazard Analysis a plus.

Position Expertise/Qualifications

• High School Diploma, required
• Associate’s Degree in Biotechnology, Life Sciences, or Surgical Technology, preferred.
• 6 months experience in
  • Biotech, laboratory or other science, required
  • Manufacturing in a GMP environment, required

Physical Requirements

• Sedentary work that generally requires sitting and/or standing