Lead Blood & Tissue Manufacturing Technican

Lead Blood & Tissue Manufacturing Technician

General Summary

Ensure that employees perform procedures compliantly by maintaining knowledge of all current Standard Operating Procedures (SOPs) and regulations.

Assist the Trainer by conducting training of new and current employees of Apheresis Platelet Processing and Quarantine Laboratory regarding STBTC policies and Standard Operating Procedures (SOPs).

Assist Platelet Processing & Product Quarantine Supervisor in the development and implementation of new procedures and other duties.

Responsible to perform component production and testing assigned to the department. 

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 (internal or external, including donors for select positions) through multiple 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

·         Exhibit leadership role by providing technical direction to staff regarding workflow and performance of daily tasks.

·         Train employees in all required job duties to include technical, quality assurance, and safety procedures.

·         Track inventory supply needs and order supplies when necessary.

·         Monitor and guide staff to perform duties in compliance with all regulations and Standard Operating Procedures (SOPs).

·         Maintain close working relationship with supervisor/management and report any irregularities, difficulties, or unusual results immediately.

·         Assist in the development and implementation of new procedures.

·         Evaluate and document competency levels through direct observation and testing.

·         Competently perform all assigned departmental duties to include performing Pre‐Analytical tasks [receipt, qualification, and preparation of components and samples] and highly complex testing on donor samples and/or biological products.

·         Perform complex mathematical calculations, evaluate test results in an accurate and timely manner, and recognize and report unusual test results.

·         Analyze quality control data and resolve discrepancies that may occur in reporting these tests. Perform STBTC laboratory quarantine procedures for blood products.

·         Accurately maintain all record and documentation of quarantine products (blood products).

·         Operate required equipment utilizing established protocols and within quality control limits.

·         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.

·         Maintain adequate level of disposable supplies through request for purchase of additional supplies, if applicable.

·         Recognize unusual results and difficulties encountered in all phases of laboratory performance to include purchased goods, environmental, mechanical and product related.

·         Assist with validation of all procedures performed thus providing for the safety and efficacy of products to include preventative maintenance.

·         Maintain a close working relationship with Management and Trainer, keeping them informed on issues pertaining to laboratory functions.

·         Review all paperwork.

·         May interact with and/or exposure to various groups, VIPs, and/or media.

Performs other duties as assigned.

Non-Essential Tasks

·         Run departmental errands as directed.

·         Know the responsibilities of the scheduling staff and perform those duties in the event of absence.

·         Assist in other Laboratory areas as directed.

·         Attend meetings, seminars, and other workshops as required.

Education

Required Minimum Education

Requires a Bachelor’s Degree from an accredited four-year college or university. The required major is Applied Science or equivalent.

Preferred Education

Prefer a Master's Degree from an accredited college or university.

Licenses and/or Certifications

·         Certified Medical Laboratory Technician (MLT) preferred.

Experience

Required Minimum Experience

·         Requires five or more years of laboratory experience.

·         Requires three or more years of Apheresis Platelet Processing and Quarantine Laboratory experience.

Preferred Experience

·         Prefer Clinical Laboratory, equipment validation, quality control, and hematology experience.

Experience Exception to Education

In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge

·         Must have knowledge of departmental budget and ability to order supplies.

·         Must have knowledge of departmental budget and ability to order supplies.

·         Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

·         Must have a working knowledge of equipment and procedures for various technologies.

·         Must recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work.

·         Must have a working knowledge in all aspects of technical procedures of a clinical laboratory.

Skills

·         Must maintain competency in skills required for Apheresis Platelet manufacturing, Component QC, Product Quarantine, and labeling.

·         Must have excellent written and oral communication skills.

·         Must have strong computer skills.

·         Must have the skills to recognize unusual results and troubleshoot testing problems as soon as detected.

·         Must be prepared to identify root causes of problems and select the best course of action when circumstances require.

·         Must have completed Train the Trainer.

·         Must have knowledge of departmental budget and ability to order supplies.

·         Must have the skills to recognize unusual results and troubleshoot testing problems as soon as detected.

·         Must demonstrate positive leadership skills.

Abilities

·         Must be capable of mentoring team members

·         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 be able to keep information confidential.

·         Must be able to provide direction and guidance to employees regarding day‐to‐day operations to ensure quality and regulatory compliance.

·         Must be able to train staff in procedures and proctor competencies.

·         Must perform well in repetitive work situations.

·         Must be able to correctly interpret test results.

·         Must be able to work with interruptions, meet deadlines, and perform accurate work and/or reports.

·         Must have exceptional attendance as outlined in the employee handbook.

·         Must be able to to assist in periodic review of SOPs.

·         Must be able to assist in the development of new SOPs and validations.

Working Environment & Travel Requirements

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.

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.

Required to carry up to 25 lbs. and occasionally lift 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.