Cell Therapy Mfg. Associate I - ACP

Bloodworks NW • Seattle, WA

2d • $32 - $48 • Onsite

About The Position

Bloodworks Northwest is seeking a Cell Therapy MFG Associate I to join their Cell Therapy programs. The incumbent will function as a member of the Bloodworks Bio Advanced Therapies department, performing technical aspects of receiving, labeling, processing, testing, storing, and distributing products and samples handled by the Advanced Therapies Laboratory. This role also involves activities related to nonconformance, data entry and review, and validation protocols. The position requires adherence to Good Documentation Practices (GDP), preparation of laboratory supplies and reagents, ensuring adequate supplies, and operating/maintaining laboratory equipment. The Associate will receive and evaluate products/samples, send samples for testing, and complete training and competency documentation. Responsibilities include initiating nonconformances, labeling, processing, testing, cryopreserving, and storing products/samples, including fractionation, cryopreservation, aliquoting, flow assays, manual cell counts, viability, and CBCs. The role also supports manufacturing and maintenance in cleanroom areas (ISO-5, -7, -8), assists with validations, and creates/modifies/maintains electronic records in compliance with FDA requirements. The Associate is expected to collaborate effectively with colleagues, work under direct supervision, and work one weekend day as part of the regular schedule. General responsibilities include modeling Bloodworks' values, maintaining confidentiality (HIPAA), functioning effectively within a team, providing feedback, communicating obstacles to leadership, complying with SOPs, recognizing and minimizing hazards, recommending improvements, supporting the department budget, establishing collaborative relationships, ensuring compliance with laws and policies, and participating in emergency drills.

Requirements

• Must qualify as Testing Personnel, Moderate Complexity Testing, under CLIA personnel requirements found in Subpart M of the Code of Federal Regulations.
• Bachelor of Science in medical technology, laboratory science, chemical, physical, or biological science (or equivalent combination of education and experience).
• Functional proficiency with MS Office applications (Word, Excel, PowerPoint, Outlook, Access).
• Knowledgeable about the safe handling of any potentially infectious material, such as blood or other biological specimens, tissues.
• Knowledgeable about applicable techniques for laboratory processing, aseptic technique, cryopreservation, storage, and distribution.
• Knowledgeable about applicable laboratory assays and testing instruments.
• 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., LN2 cylinders) is required.
• The ability to lift and carry up to 50 pounds throughout the workday is required.

Nice To Haves

• Experience with flow cytometric analysis is desirable.
• Experience with ISO-certified cleanrooms is desirable.
• Experience with operating biological safety cabinets (BSCs) is desirable.

Responsibilities

• 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.
• 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.

Benefits

• medical, dental, vision, and life insurance, with family coverage also available.
• retirement plans (401a & 401b)
• consolidated paid leave program (4.8 – 6.8 weeks of time off accrued per year, based on length of service)
• subsidized transit program
• educational reimbursement
• relocation assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level