Summary: Perform any one or all of the routine processes (e.g., dissection, layout, cutting, and vialing) in laboratory setting according to established procedures and guidelines. Produce high quality products in an efficient manner. Ensure sterile processing and handling of tissue. Perform regular inspection and cleaning of lab equipment to ensure equipment is in good, working order. Monitor equipment maintenance schedule to ensure routine and repair service is performed as needed. Perform data entry tasks.
Specific Responsibilities:
- Process human tissue in an aseptic processing environment (lab) according to standard operating procedures and work instructions using surgical instruments and machinery.
- Perform any one or all of the routine tissue processes (e.g. dissection, layout, cutting, and vialing), as per required specifications, within expected processing times in order to meet production schedules.
- Adhere to all policies and practices from the Quality Management System (QMS) based on company standards and regulatory standards for tissue processing.
- Document results of each process performed, supplies used, etc. to maintain integrity and traceability of donor.
- Enter relevant data from tissue processing record into company specific database.
- Monitor, maintain, and clean processing facility and equipment.
- Support and contribute new ideas to the continuous tissue processing improvement efforts.
- Monitor tissue processing supplies and notify management when supplies are needed; restock supplies.
SKILLS/COMPETENCIES
- Proficient in Microsoft Office (Word, Excel, etc.)
- Solid organization skills to support the efficiency of the laboratory operations.
- Ability to effectively work and interact with all members of the laboratory, tissue processing, research & development, and tissue recovery functions.
- Must show aptitude to develop appropriate skills needed for the job.
- Unquestioned integrity and ethics with a confident but well-grounded approach to doing work.
EDUCATION/EXPERIENCE:
- High School Diploma required; BA/BS in life sciences preferred.
- Minimum 6-12 months in biotech, pharma, medical or clean manufacturing.
- Prefer knowledge of Good Documentation Practice (GDP), Good Tissue Practice (GTP), Good Manufacturing Practice (GMP) and AATB regulations.
WORK ENVIRONMENT:
The work is typically performed in a controlled laboratory environment. Will have contact/exposure with bio-hazardous materials, chemicals, and blood and human tissue. Training will be conducted on the handling and safety practices necessary for the use and disposal of hazardous chemicals and potential biohazards. Will also be trained on all applicable equipment needed to perform the job.