Cell Therapy Mfg. Associate I - ACP

Cell Therapy MFG Associate IBloodworks Northwest is backed by more than 70 years of Northwest history and 250,000 donors. A national leader in transfusion medicine, Bloodworks has been chosen to serve more than 90 hospitals in Washington, Oregon and Alaska – partnering closely with local hospitals to deliver the highest level of patient care. Patients with traumatic injuries, undergoing surgeries or organ transplantation, or receiving treatment for cancer and blood disorders all depend on our services, expertise, laboratories and research. We are local, nonprofit, independent, volunteer-supported and community-based. We have a fantastic new job opportunity for a Cell Therapy MFG Associate I to join our Cell Therapy programs here at Bloodworks. The incumbent should function as a member of the Bloodworks Bio Advanced Therapies department, performing the technical aspects of receiving, labeling, processing, testing, storing, and distributing products and samples handled by the Advanced Therapies Laboratory. Additionally, performs activities related to the nonconformance process, data entry and review, and validation protocols. Principal responsibilities include, but are not limited to: Consistently model values of Bloodworks and coach for the same expectation; contribute and build upon current practices and procedures in support of values, mission, and goals. Always follow Good Documentation Practices (GDP).Prepare laboratory supplies and reagents. Ensure an adequate supply of the equipment and supplies required for processing and testing. Operate and maintain laboratory equipment and instruments. Receive and evaluate the acceptability of products and samples. Send samples for testing and receive test results. Complete training and competency documentation for special equipment and pertinent regulations controlling these products. Initiate departmental nonconformances. Label, process, test, cryopreserve, and/or store products and samples, including: Fractionation, cryopreservation, and aliquoting Flow assays, manual cell count and viability, and CBCs. Support manufacturing and maintenance activities in classified ISO-5, -7, and -8 cleanroom areas. Assist with executing validations. Create, modify, maintain, and transmit electronic records in a controlled and approved manner in conformance with FDA requirements. Fully participate as a member of the Advanced Therapies and Bloodworks teams by ensuring interactions with colleagues promote collaboration and effective communication. Perform most work under direct supervision. Work one weekend day as part of the regular schedule. General responsibilities include, but are not limited to: Consistently model Bloodworks' values; contribute and build upon current practices and procedures in support of values, mission, and goals. Maintain confidentiality of donor and patient medical, financial, and personal information in accordance with HIPAA and other applicable standards/guidelines. Function effectively within the team; participate and contribute constructively to produce results collaboratively; exhibit respect for others as well as willingness to help others. Positively challenge and support peers to ensure all contribute to the organization's success. Provide timely, honest feedback to team members to improve team performance. Communicate with leadership about any obstacles to personal growth or team success. Comply with all applicable Standard Operating Procedures (SOP) as written. Recognize potentially hazardous materials, equipment, and situations and follow safety procedures to minimize risk to self and nearby individuals. Proactively recommend systems, resources, and procedures to achieve the department's success. Responsibly support the department budget by avoiding late lunches and unnecessary overtime, minimizing reagent/material waste, and promptly communicating low supply levels. Establish and maintain collaborative relationships with internal and external customers to contribute to the success of the department and the organization. Ensure the department's actions comply with laws, regulations, and organizational policies and practices. Participate in Bloodworks-mandated emergency drills. Perform other duties as assigned.

Familiarity with cGMP, cGTP, and cGLP.Familiarity with regulations/guidelines for cleanroom operations (e.g, ISO 14644, EU GMP Annex 1).Require the ability to comprehend the criticality of the testing being performed, as it relates to the blood components being prepared for transfusion, or organs being transplanted. Includes a fundamental understanding of the financial value of the testing reagents, blood components being prepared, and the necessity to follow all regulatory rules and regulations (AABB, CFR, CLIA, FACT, NMDP, HIPAA, and State), including the FDA's "Good Manufacturing Practices."ability to work independently with a high degree of accuracy and attention to detail. Required mental activities include the ability to read, write, comprehend, and speak English (all of which are used frequently). Other required mental activities include interpersonal skills, teamwork, decision-making, prioritization, teaching, supervising, multitasking, problem-solving/analysis, independent judgment/action, performing basic math, and basic programming. Required physical activities include frequent standing, sitting, walking, talking, hearing, reaching, handling, feeling, and repetitive hand and wrist motions. Other required physical activities are used less frequently: bending (occasionally), stooping, kneeling, and climbing (all used rarely).The ability to push and pull an average of 200 pounds with mechanical assistance (e.g., LN 2 cylinders) is required. The ability to lift and carry up to 50 pounds throughout the workday is required.