Associate I, Manufacturing

BioTissue; Miami (FL); On-site; USD 36,000 - 60,000; Full time

Job summary

BioTissue in Florida seeks a hands-on Processing Technician to support the processing and manufacturing of Human Transplant Tissues and devices in an FDA-regulated GMP facility. You will thaw placental tissues, prepare solutions, and ensure production control, labeling and documentation for each unit.

Ideal candidates will have strong English communication, meticulous attention to aseptic conditions, and the ability to multi-task in a fast-paced environment.

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.

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) 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

Communication

Multitasking

Microsoft Office

GMP familiarity

Quality documentation

Education

High School Diploma

Associate's Degree in Biotechnology/Life Sciences/Surgical Technology

Job description

Position Summary

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

E ssential 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.

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