Associate I, Manufacturing

About the Role

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

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 changeover 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 and report equipment and facility problems and any potential deviation during processing.

Requirements

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

Skills

• Excellent communication skills; fluent (oral/written) English.
• Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional environment.
• Effective and appropriate communication, using good judgment on what to communicate and to whom.
• Clear and credible verbal communication, selecting the right tone for the situation and audience.
• 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).

Physical Requirements

Sedentary work that generally requires sitting and/or standing.