Overview
Consumer Safety Inspector Jobs in Georgetown, DE at USDA Food Safety and Inspection Service
Description:
Company Overview:
BioStem Technologies, founded in 2014 and located in South Florida, is a leading medical technology company focused on advanced wound care and regenerative medicine. We develop and commercialize placental tissue allografts, cutting-edge wound care products, and surgical solutions aimed at improving patient outcomes. As we continue our rapid growth and expansion we are seeking a 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:
Including 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)
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.
Requirements:
Qualifications:
Candidate must be employed in good standing with BioStem Technologies for a minimum of 1 year
Must be a Subject Matter Expert in a minimum of 1 topic
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 accommodation 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.
Other PPE such as gloves, sleeves, aprons and/or gowns may apply when inspecting equipment and during production in the operations area.
BioStem Technologies Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Title: Consumer Safety Inspector
Company: USDA Food Safety and Inspection Service
Location: Georgetown, DE
