Ensure that SOP’s and specifications for all processing related activities are current. Conduct periodic procedural audits to ensure compliance with LifeLink SOPs and AATB Standards. Specific areas of responsibility include, but are not limited to: review of processing records, data entry and collection, records management and inspection of tissue. Additional responsibilities include supply and tissue inventory management.
- Ability to qualify and perform the functions and responsibilities of a circulator in order to appropriately observe and audit processes and procedures.
- Ability to load, unload and maintain Freeze Dryers.
- Prepare and review all associated documentation for monthly bioburden and quarterly dose audits.
- Assist in SOP development related to process improvements and lean initiatives.
- Participate in the evaluation of improved safety standards and procedures designed to protect employees from environmental and equipment hazards.
- Identify improvements in documentation processes, including electronic modules.
- Create and perform training for technical staff as directed.
- Preparation of RRR and Reprocessing packets, as well as all task associated with Optecure.
- Assist with QC of records/logs, including but not limited to lyophilizer records, various temperature records, freezer recording charts, human waste manifest, cleaning and decontamination logs, inventory logs and processing records.
- Ability to perform the QC of allografts in conjunction with QA Support.
- Coordinates and performs quality control audits of tissue bank processes to ensure compliance with LLTB and AATB standard operating procedures.
- Responsible for generating reports, records and labels to ensure uninterrupted daily production for Processing and Central Services.
- Compile, track and trend all Processing LEAN metrics, monthly production adherence, and other data as directed.
- Review and analyze various reports ensuring accuracy and completeness of data entry (e.g., out of spec report, discrepancy report).
- Responsible for handling Stericycle pickups and review of biohazardous waste tracking.
- Responsible for tracking, maintaining and ordering supplies and equipment for Processing and Central Services.
- Perform periodic cycle counting and maintain freezer, Nitrogen tank, and in-process bin inventory.
- Ensure produced allograft inventory is properly allocated.
- Facilitate communication between Processing and the Lab.
- Backup to processing QC Specialist.
- Work requires an Associate’s Degree and three years Tissue Banking experience and hold certification of AATB Certified Tissue Bank Specialist or;
- Work requires an Associate’s Degree and three years Tissue Banking experience with the ability to obtain certification of AATB Certified Tissue Bank Specialist within 2 years.
- Work requires the ability to stand for ninety percent of the work time.
- Work requires the interpersonal ability to interact with staff, supervisors and management.
- Work requires the physical ability to lift and carry equipment up to fifty pounds.
- Work requires the mental ability to implement and oversee the documentation requirements necessary to conform to the standards of the procedure manual, AATB standards, OSHA requirements and all other relative agencies.
- Work requires strong computer, communication and writing skills.
- Excellent organizational skills, ability to multi-task, and a high level of attention to detail.
LifeLink offers a wonderful benefits package to include company paid medical and dental premiums, life insurance, disability insurance and a generous company paid pension plan. EOE.