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. 

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