Cell Therapy Mfg. Associate I - ACP

Cell Therapy Mfg Associate I

Bloodworks 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.

Requirements:

Educations & Experience:

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

Specific job skills include, but are not limited to:

• Maintain competency and proficiency in departmental Core Policies, Processes, and Procedures beyond the initial 6 months of hire to the current position.
• 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., LN 2 cylinders) is required.
• The ability to lift and carry up to 50 pounds throughout the workday is required.

Working Conditions:

• This is a highly regulated position and is subject to various rules and regulations from regulatory agencies and accrediting bodies. These may include, but are not limited to, FDA, FACT, AABB, CLIA, CAP, ISO, and USP.
• Job conditions to be expected include on-call status (per departmental policies and position level), constant standing, and extensive close work at computer screens (occasional).
• ability to work scheduled holidays and weekends.
• Bloodworks is a community-supported non-profit organization. As such, an incumbent can expect to work with volunteers from time to time.
• As this is an essential position with direct responsibility to donors and/or patients, the incumbent should be prepared to work extended shifts, even during periods of inclement weather or other emergencies.
• This position has direct exposure to bloodborne pathogens.
• The work area may utilize powerful magnets. Pacemakers and other objects that respond to strong magnetic fields may be affected.
• Telecommuting is a rare, temporary condition for this role.

Benefits and Perks:

Employees regularly scheduled for 24+ hours per week are covered by medical, dental, vision, and life insurance, with family coverage also available. Also able to participate in 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, and educational reimbursement. Candidates hired from