Under the direction of the Processing Supervisor, the Manufacturing Operator will perform hands-on execution of all routine sterilization processes for manufacturing located at the Tissue Bank.
This role will focus on the safe operation of all major equipment for processing.
Other duties may include sterile and non-sterile activities such as dissection, membrane processing, and packaging in controlled environments in accordance with established procedures and regulated guidelines.
This position is fulltime and may require availability 7 days a week, including late hours and weekends when necessary.
Essential Functions
This role should be able to perform the following in accordance with AATB, FDA, and Tides Medical stated policies and procedures while upholding Tides Medical’s mission and corporate values:
Maintain confidentiality of all records and information, which pertains to donors, families, employees, the organization, and related areas
Cleans and sanitize work area, all equipment, and all supplies
Demonstrate a working knowledge of the Standard Operating Procedures
Operate processing equipment with a deep understanding of the machinery
Abide by all safety protocols in place for operation of equipment
Sterilize membrane using in-house equipment or packaging appropriate for 3rd party sterilization
Basic troubleshooting of equipment throughout the process
Document all processing activities performed accurately to maintain integrity and traceability of donor
Aseptically process HCT/Ps according to Standard Operating Procedures
Perform any and all of trained processes within expected processing times in order to meet production scheduling
Effective operation, cleaning, maintenance and care of processing equipment under supervision
Demonstrate an understanding of proper settings for processing equipment
Qualifications:
Requirements:
A High School Diploma; higher education/ certification preferred
2 years of previous experience in a regulated industry
Demonstrated mechanical aptitude for operation of equipment
2 years of previous experience operating equipment with an understanding of basic safety requirements
Strong interpersonal and organizational skills; excellent attention to detail
Excellent oral, written, and interpersonal communication skills
Proficient in Microsoft Office
Capability to develop the necessary skills required for the job functions
Physical demands:
Must be able to stand for the full duration of a shift
Must be able to lift a minimum of 25 pounds
Must be able to write clearly and legibly
Mental demands:
Must be able to manage multiple tasks and prioritize workload
Environmental demands:
Must be able to complete tasks independently
Must be able to work in an isolated cleanroom for 8 hours at a time
