Team Leader Processing MTF

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities.

Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles.

The Team Leader is responsible to assist the Supervisor and provide direction to the Processing Technicians in an aseptic processing controlled and regulated medical device environment. The Team Leader is responsible to promote teamwork, safety, and quality while meeting the departments processing goals. The majority of the Team Leaders time (85%) will be spent in the ISO (International Organization for Standardization) certified clean room environment monitoring processing activity. The Team Leader will ensure adherence to: procedure, proper paperwork documentation, traceability and line clearance. The Team Leader will communicate clearly and tactfully to the team.

• Promote attentiveness to Safety, Quality, Teamwork and Productivity.
• Perform process and paperwork reviews to ensure adherence to standard operating procedure.
• The Team Leader will have a working knowledge of the process area he/she oversees and may assist in processing of tissue as needed.
• Follow a schedule and provide the team with an effective plan to meet the daily goals.
• Ensure the team is following operational procedures, work instructions and specifications.
• Assist the Supervisor and provide direction within a busy and time sensitive environment.
• Lead by example; follow the code of conduct as well as demonstrating proper aseptic technique.
• Maintains an organized work environment. Organize the process flow, donors, paperwork, work orders, supplies and equipment.
• Participate in Team Meetings and training meetings.
• Keep all necessary logbooks neat, organized and up to date.
• Perform Safety, Quality and Housekeeping observations as requested.
• May be requested to assist the Supervisor and provide feedback regarding technician’s performance.
• Work with Process Engineering to ensure timely execution of preventive maintenance of processing equipment.
• Shift turnover- Communicate state of lab with relieving Team Leader.
• May train technicians or new hires.
• Prepare chemicals and cleaning solutions as needed as per procedure.
• Work with a wide range of equipment including sharps and cutting tools in an ISO controlled environment while following safe work practices.
• Work with potential biologic hazardous waste and materials.
• May be required to work weekends and/ or off hours when necessary to meet organizational needs.
• Prepare and return the cleanroom before and after quarterly shutdown maintenance activities.
• Assist on special projects and perform additional duties as assigned.

MINIMUM QUALIFICATIONS

Education:  High School Diploma/GED

Years of Experience:  3-5 years

Other:   3 years’ experience in one of the following: tissue banking, surgical technician, nursing or related medical technology background, medical device or pharmaceutical manufacturing or production type environments, ISO class 8 or less clean room / controlled environment.

Specific Licenses and/or Certifications:

Specialized Knowledge, Technical Skills, and Abilities:

• Demonstrated written and verbal communication skills.
• Demonstrated attention to detail, including consistent documentation skills.
• Demonstrated interpersonal skills coupled with strong leadership abilities.
• Demonstrated ability to organize work of self and others.

PREFERRED QUALIFICATIONS

Education:  College Coursework in science, business or relevant field or College degree – Business, Science or relevant field.

Years of Experience:  4-6 years

Other:   4+ years’ experience in one of the following: tissue banking, surgical technician, nursing or related medical technology background, medical device or pharmaceutical manufacturing or production type environments, ISO class 8 or less clean room / controlled environment.

Specific Licenses and/or Certifications:   Other

Specialized Knowledge, Technical Skills, and Abilities:

• Current Good Manufacturing Practices (cGMP’s – FDA Code of Regulations 21 CFR Part 210 & 211),
• Quality System Regulations (QSR’s – FDA Code of Federal Regulations 21 CFR Part 820).
• Current Good Tissue Practices (cGTP’s – FDA Code of Federal Regulations - 21 CFR Part 1271).
• Work environment - ISO 14644-1 Classification 4 – 8, Federal Standard 209E - Class 10 – 100,000