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A leading biomanufacturing organization is seeking a Blood & Tissue Manufacturing Technician I. The technician will focus on blood component processing, ensuring adherence to regulatory standards while performing testing and quality control duties. Successful candidates will have a strong background in laboratory procedures and will embody the company's core values of accountability and integrity, fostering a quality-driven work culture.
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Join to apply for the Blood & Tissue Manufacturing Technician I, BBG AT Processing Lab role at BioBridge Global
BBG Advanced Therapies is a full-service biomanufacturing organization that delivers comprehensive, cell and cell-based manufacturing solutions for advanced therapies. Leveraging its showcase facility designed to be compliant with FDA, EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on translating and refining early-stage processes to scale for commercial readiness.
General Summary
Responsible to perform and specialize in one of the two areas (Platelet Processing or Quarantine of blood components). This includes blood component accessioning, sampling, quality control, maintenance, testing, component manufacturing, final labeling, and quarantine procedures. Ensures all laboratory procedures and processes are conducted in compliance with prescribed regulations. Maintains all technical activities to include training and the performance of moderate complexity, routine laboratory procedures. Maintain accurate records and documentation as well as recognize unusual test results and resolve discrepancies. Maintain excellent communication with the department and throughout the organization.
Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.
Provide world class customer service by capturing and being responsive to the voice of the customer (including donors) through established feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.
Major Duties And Responsibilities
Essential Tasks
Competently perform all assigned departmental duties to include performing Pre-Analytical tasks [receipt, qualification, and modification of components, and samples] and testing on blood products.
Perform complex mathematical calculations, evaluate test results in an accurate and timely manner, and recognize and report unusual test results.
Accurately maintain all record and documentation of quality control.
Analyze quality control data and resolve discrepancies that may occur in reporting these tests.
Operate required equipment utilizing established protocols and within quality control limits.
Perform STBTC laboratory quarantine procedures (of blood components).
Perform calibrations, quality control, and maintenance on equipment used in the performance of duties. Recognize equipment malfunctions and/or technical problems and take appropriate technician level steps to resolve.
Use independent judgment and/or knowledge to resolve complex problems.
Perform product labeling and investigate any issues which prevents labeling.
Perform computer entry of component modifications accurately.
Be knowledgeable and follow established South Texas Blood & Tissue Center laboratory guidelines, policies and procedures for biological and chemical safety.
Perform laboratory testing through performance of moderate complexity, routine, and special laboratory procedures.
Coordinate activities of the laboratory to determine priorities regarding processing of units and testing as needed.
Utilize the data management system to include Outlook, Excel, Word, and MAC.
Maintain adequate level of disposable supplies through request for purchase of additional supplies, if applicable.
Assist in the preparation of daily activity reports related to processing, resolution of discrepancies, and retention of products not qualified for release.
Assist with training of new employees as needed and maintain annual training competencies for the testing laboratory.
Recognize unusual results and difficulties encountered in all phases of laboratory performance to include purchased goods, environmental, mechanical and product related.
Assist and develop testing procedures according to organizational and regulatory (NMDP, AABB, FACT, ISO, FDA, and cGMP) standards.
Assist with validation of all procedures performed thus providing for the safety and efficacy of products to include preventative maintenance.
Attend Meetings, Seminars, And Other Workshops As Required.
Maintain a close working relationship with management keeping them informed on issues pertaining to laboratory functions.
Review all required paperwork.
Performs other duties as assigned.
Non-Essential Tasks
Run departmental errands as needed.
May interact with and/or exposure to various groups, VIPs, and/or media.
Assist in other Laboratory areas as directed.
Education
Requires an Associate Degree from an accredited college or university in a specialized area. The required major is Clinical Laboratory Science or equivalent.
Prefer a Bachelor’s Degree from an accredited college or university. The preferred major is Applied Science or equivalent.
Licenses and/or Certifications
Certified Medical Laboratory Technician (MLT) preferred.
Experience
Requires two or more years of laboratory experience.
If Bachelor's Degree is attained, no specific work experience required.
Prefer Clinical Laboratory, equipment validation, quality control, and hematology experience.
Knowledge
Must have a working knowledge in all aspects of technical procedures of a clinical laboratory.
Must recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work.
Must have a working knowledge of equipment and procedures for various technologies.
Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.
Skills
Must be prepared to identify root causes of problems and select the best course of action when circumstances require.
Must have the skills to recognize unusual results and troubleshoot testing problems as soon as detected.
Must have strong computer skills.
Must have excellent written and oral communication skills. This includes responding to emails in a timely manner.
Must maintain competency in skills required for Apheresis Platelet manufacturing, Component QC, Product Quarantine, and labeling.
Must be competent in processing and testing equipment required in a clinical laboratory.
Abilities
Must be a self-starter and self-directed worker.
Must be able to keep information confidential.
Must be able to make good sound judgment decisions.
Must be neat in appearance and well groomed.
Must be professional, detail oriented, self-motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.
Must perform well in repetitive work situations.
Working Environment
Works in a well-lighted air conditioned and heated laboratory/department. May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment. May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment. May have bodily exposure to refrigerator/freezer temperature, especially hands and face. Will work extended hours during peak periods. May be required to work any time of the day, evening or night during the week or weekend. Occupational Exposure Assignment - Category I
Physical Requirements
Will sit, stand, walk, and bend during working hours.
Requires ability to reach, lift and carry up to 50 lbs.
Requires manual and finger dexterity and eye-hand coordination.
Requires normal or corrected vision and hearing corrected to a normal range.
We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!
All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:
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