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Job Description

About BioLife Plasma Services

Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

OBJECTIVES/PURPOSE

Responsible for assisting the Training Supervisor in the general administration of the center area training program. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician when not acting as the Training Lead. Fully trained in all Medical History, Phlebotomy, and Sample Processing job skills. Position will provide oversight of operational flow, assist in training new and existing employees, and pro- vide leadership to staff.

All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.

ACCOUNTABILITIES

• Perform duties associated with Training (including but not limited to): (40%)
  • Maintains complete and accurate records to ensure that all personnel are competent to perform their assigned duties.
  • Reviews employee training materials to meet initial and annual certification requirements.
  • Ensures timely completion of cross-training and annual re-certification training.
  • Monitors center training needs and performs cross-training, re-training, SOP training, preventative action training and other training as needed.
  • Works closely with the Training Supervisor and management team to communicate center/employee needs as they relate to training.
  • Communicates regularly with the Training Supervisor and Center Management to ensure compliance with training requirements and that adequate support is provided to employees in the work area.
  • Review Quality Control Records as applicable and assigned
• Maintain certification and perform all required duties in the area of Phlebotomy (including, but not limited to): (10%)
  • Perform venipuncture of donors and programming of plasmapheresis machine.
  • Monitor donors during donation process and manage donor reactions.
  • Perform all duties required for the setup, verification, operation, and trouble-shooting of plasmapheresis equipment per SOP, within scope of training. Also, maintain and calibrate equipment.

Maintain certification and perform all required duties in the area of Medical History (including, but not limited to): (10%)

• Take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system.
• Perform fingerstick, test sample, and record other donor measures to include hematocrit, total protein and weight.
• Enter donor information into the Donor Information System (DIS).
• Coordinate donors to donor floor and compensate donors using the Debit Card system.
• Maintain certification and perform all required duties in the area of Sample Processing (including, but not limited to): (10%)
  • Prepare units for frozen storage.
  • Collect and store samples from plasma units for testing.
  • Perform routine maintenance on the freezer including monitoring freezer and refrigerator temperatures and removing ice buildup.
  • Prepare frozen plasma units and samples for shipping following established protocol.
  • Manage supplies, assist management team with inventory control procedures, break down empty car- tons and assist with proper disposal
• Maintain certification and perform all required duties of Lead Technician (including, but not limited to): (20%)
• Monitors the production areas and donor flow to ensure employees meet goals and comply with company quality standards and procedures.
• Perform change of lot number for soft goods.
• Perform quarterly and annual tube sealer cleaning
• Prepare a non-conforming event log entry, counsel employees on Level 1 non-conforming events, and enter appropriate information into database.
• Coordinates and performs new employee orientation, including company background, health and safety requirements, policies and procedures and other company expectations. (10%)

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• A minimum of one year of relevant work experience, or an equivalent combination of education and experience.
• Prior certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician).
• Completion of all training through Lead Technician.
• Demonstrated understanding of center operations in an FDA-regulated environment.
• Effective communication, organizational, and technical/problem-solving skills.
• Demonstrated work history of above average performance, customer service, and attendance.
• Effective oral and written communication skills.
• Demonstrated ability to organize and direct the work of others and resolve conflicts effectively.
• Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
• Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
• Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.

Leadership

• Integrity
• Fairness
• Honesty
• Perseverance
• Putting the patient at the center
• Building trust with society
• Reinforcing our reputation
• Developing the business

Decision-making and Autonomy

• Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
• Refers to management team for escalated donor/employee concerns (internal)

Interaction

• Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
• Attend staff meetings and other team meetings as required.
• Good verbal communication and customer service skills.
• Ability to multi-task and work as a team player.

Innovation

• Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.

Complexity

• Production environment requiring the ability to walk and stand for the entire work shift.
• Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
• Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. – 50 lbs.
• Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
• Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential: High School Diploma or equivalent required

Desired: Associate or Bachelor's degree preferred

ADDITIONAL INFORMATION

• FLSA Classification (US) - Non-Exempt
• Other duties and responsibilities as assigned.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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