What are the responsibilities and job description for the Associate I, Manufacturing position at BioTissue Holdings Inc?
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