Cell Therapy Mfg Associate I - ACP

• Operate and maintain laboratory equipment and instruments.
• Process products and coordinate completion of testing (within and outside of Bloodworks), including:

• Fractionation, cryopreservation, acquisition and distribution of appropriate samples for testing (microbiology, serology, cell counts, & QC).
• Accurately labeling all materials.
• Perform QC assays as necessary (enumeration via flow cytometry, colony forming assays, microbiology); and
• Ensure adequate stock supplies and equipment required for processing and testing.
• Complete training and competency documentation for advanced cell processing on special equipment and pertinent regulations controlling these products.
• Perform batch record review for completeness and accuracy.
• Perform data entry in paper or electronic database.
• Perform logbook review for completeness and accuracy.
• Perform equipment quality control and assist with validation.
• Initiate departmental deviations and investigations.
• Assist in the revision of departmental SOPs and forms.
• Assist in the execution and completion of approved validation protocols.

• Consistently model Bloodworks’ values; contribute and build upon current practices and procedures in support of values, mission, and goals.
• Ensure department’s actions complies with laws, regulations, and organizational policies and practices.
• Function effectively within the team; participate and contribute constructively to produce results in a collaborative manner; exhibit respect for others as well as willingness to help others.
• Challenge and offer support to peers to ensure all are contributing to the success of the organization.
• Provide timely and honest feedback to team members regarding the functionality of the team.
• Recognize potentially hazardous materials, equipment, and situations and follow safety procedures to minimize risk to self and nearby individuals.
• Responsibly support the department budget.
• Proactively recommend systems, resources, and procedures to achieve department’s success.
• Participate in Bloodworks mandated emergency drills.
• Maintain confidentiality of donor and patient medical, financial, and personal information in accordance with HIPAA and other applicable standards/guidelines.
• Complies with all applicable Standard Operating Procedures (SOP) as written.
• Perform other duties as assigned.

• 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, or biological science (or equivalent combination of education and experience).

• Maintain competency and proficiency in Advanced Therapies Processes and Procedures beyond initial 6 months of hire as Cell Therapy Mfg Associate I.
• 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 specimen blood and tissues.
• Knowledgeable about applicable techniques for laboratory processing, aseptic technique, cryopreservation, storage, and distribution
• Knowledgeable about applicable laboratory assays and testing instruments
• Knowledgeable about applicable regulations, such as cGMP, cGTP, CLIA.
• Knowledgeable about applicable cellular therapy standards and industry organizations, such as AABB, FACT, NMDP.
• Ability to work independently with high degree of accuracy and attention to detail.
• Required mental activities include the ability to read, write, comprehend, and speak English (all used frequently). Other required mental activities involve interpersonal skills, teamwork, decision-making, prioritization, teaching, supervising, multi-tasking, problem solving/analysis, independent judgment/action, performance of basic math, and basic programming.
• Required physical activities include frequent standing, sitting, walking, talking, hearing, reaching, handling, feeling and repetitive motions of hands/wrists. Other required physical activities used less frequently include bending (used occasionally); stooping, kneeling, and climbing, (all used rarely).
• Ability to occasionally push and pull an average of 200 pounds is required.
• Ability to frequently lift and carry an average of 50 pounds throughout the workday is required.

• This is a highly regulated position and is subject to meeting various regulatory requirements and accrediting agencies standards.
• Job conditions to be expected include regular weekend work and occasional evenings and holidays. Participate in on-call duties per departmental policies.
• As this is an essential position with direct responsibility to donors and/or patients, incumbent should be prepared to work extended shifts, even during periods of inclement weather or other emergencies.
• This position has direct exposure to blood borne pathogens.

Bloodworks Northwest