Specialist, Production Support

Company: Bio-Tissue, Inc.
Location: Miami
Posted on: May 28, 2023

Job Description:

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Specialist, Production Support Full Time Clerical Miami, FL, US 30+ days ago Requisition ID: 1353 Position Title:Production Support SpecialistFLSA Classification:Non-ExemptDepartment:ProcessingEmployment Type:Full TimePosition SummaryThe Production Support Specialist will be responsible for supporting the manufacturing and processing operations of human birth tissue and final products in an FDA regulated environment.This role will also be responsible for reporting issues and ensure production targets, Key Performance Indicators (KPIs), and quality standards are met.

• Perform daily inventory checks of materials available for production and communicate with supply chain whenever restock is needed.
• Ensure the cleanroom and other manufacturing areas always have sufficient materials/components needed for processing (will be required to enter the cleanroom regularly).
• Process reusable instruments/tools/equipment (clean, package, sterilize, inspect, label).
• Responsible for ensuring that materials are provided following FEFO (first expire first out) and monitored to ensure that all material/components in production are within expiration date.
• Supporting with the transfer and thawing of birth tissue for manufacturing.
• Supporting with the selection and organization of batch records.
• Responsible for completing requisitions for product samples and submitting them to the designated laboratories for testing.
• Perform data entry in the ERP system and generate labels.
• Perform final product inspection and labeling.
• Complete documentation following cGMPs and GDP.
• Responsible for handling Biohazard waste, cleaning and sanitizing the GMP facility as needed.
• Perform general office duties such as: filing, typing, labeling, copying and shredding confidential documents.
• Responsible for providing feedback on continuous improvement opportunities. -
• Responsible for checking cleanroom parameters for release.
• Responsible for being on-call for any off-hour issues.
• Document/report equipment and facility problems and any potential deviation.
• Responsible for performing administrative duties such as but not limited to filing, copying, scanning, and archiving documents as needed.Minimum Years of ExperienceType of ExperienceRequired/Preferred1 yearInventory control and stockingRequired1 yearAdministrative supportRequired1 yearPrevious work experience in a GMP environmentPreferredADA StatementCandidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the essential functions of the position with a reasonable accommodation.

Keywords: Bio-Tissue, Inc., Miami , Specialist, Production Support, Professions , Miami, Florida