The focus of this position will be Milling and Grinding. This position is a key member of the Aziyo Biologics team and as such is involved in executing the Company’s short- term goals and objectives as it relates to production. The Milling Technician is responsible for manufacturing and staging quality allografts efficiently, accurately, safely and on time. The Milling Technician utilizes equipment, in-process instrumentation and supplies to manufacture products in accordance with Aziyo’s established procedures.
Position reports to Manager, Production.
Essential Duties & Responsibilities
- Adheres to all current Standard Operating Procedures (SOP). Understands and practices universal precautions.
- Responsible for Staging of Products from Pre-Preservation to Release of Allografts to Customer Service or Distribution such as:
- Working with team lead to identify and expedite priorities based on customer requirements.
- Package and or repackage allografts as required. Store allografts, lot or batch in its correct quarantined location.
- Upon completion of lyophilization run, pull and test samples for residual moisture analysis.
- Inspects Label and Package allografts in accordance to specifications.
- Responsible for Cortical Ground Bone Fabrication, Milled Allograft Fabrication, Demineralization and Packaging.
- Package and submit samples for bioburden and sterility testing.
- Works with chemical solutions during process and testing.
- Responsible for understanding the sterilization run preparation process per SOP for each product family.
- Responsible for coordinating sterilization runs with the sterilization site and courier service including delivery and pick-up of sterilization lots, or in case of unavailability, will be required to transporting of lots to sterilization site.
- Responsible for receiving sterilization lots from the sterilization site, scanning grafts into the database and storing the lot in the appropriate storage location.
- Upon completion of sterilization run, pull grafts for histology, and microbiology samples
- Responsible for keeping adequate inventory of all supplies for sterilization run shipping and packaging and availability of forms at all times and ordering replenishment of stocks when inventory is low.
- Prints and inspects labels. Package and label all grafts after completion of sterilization lots. Maintains inventory of labeling supplies and reordering when necessary.
- Performs final inspection of allografts after labeling ensuring the allograft is in accordance with specifications, correct expiration dates and storage requirement per preservation type.
- Responsible for tracking and moving grafts to its correct location by scanning and updating logs.
- Informs facilities with routine calibration and maintenance of equipment. May perform limited troubleshooting activities as required.
- Provides general support to Production Team and Quality Assurance Team.
- Provides training and documentation requirements when necessary to new team members or other staff.
- Contributes to the development of standard operating procedures, batch records, equipment logs and other document history or traceability of tasks performed.
- Performs special projects, single tasks or other related work as required or requested.
- Contributes new ideas or techniques which may result in better service or improved quality of Aziyo products and processes.
- Responsible for following guidelines for safe working environment and report unsafe conditions to supervisor.
- High School Diploma or equivalent. Some college preferred.
Experience and Skills
- 2 years of relevant work experience.
- Strong written and verbal communication skills.
- Strong PC and data entry skills.
- Demonstrated experience working in a team environment, while maintaining cooperative working relationships.
- Demonstrated experience managing multiple projects simultaneously with strong attention to detail.
- Maintains confidentiality of all records and information, which pertains to donors, families, employees, the organization and related areas.
- Works well under pressure with strict deadlines.
- Available and adaptable to working fluctuating schedules, including weeknights, weekends, holidays and overtime as required.
- Must have the ability to lift 50 lbs. or more.
- Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
- Ability to distinguish colors.