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Corporate Opportunities

Clinical Laboratory Scientist, CLS

Remote
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Job ID R0064735

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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.

Base Salary Range: $130,000 - $140,000/Year based on candidate’s professional experience level. Employee may be eligible for Short Term and/or Long Term incentive benefits. Employees may also be eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off

OBJECTIVES/PURPOSE

Responsible for performing Technical Consultant job functions in accordance with 42 CFR 493.1411, CA regulations CAL Code 17:1036.2 including established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and Takeda and BioLife policies, procedures and quality initiatives.

ACCOUNTABILITIES

Clinical Laboratory Scientist will be responsible for Technical Consultant job functions as described in the 42 CFR 493.1411, CA statutes CAL Code 17:1036.2 to include:

Moderate Complexity and Proficiency Testing (50%):

  • Moderate Complexity Evaluations
    • Conduct initial evaluation for newly trained/supporting staff and reassessment every 6 months
  • Quarterly Moderate Complexity Review Meeting
    • Meet with the Laboratory Director and Center Management to discuss all items/issues related to Moderate Complexity that occurred during the previous quarter.
  • Proficiency Testing
    • Work with the Laboratory Director to oversee and assist with the Proficiency training and testing
  • Variability Testing
    • Oversee the performance during the Cycle 1 & 3 of Proficiency Testing. Perform reviews as required by SOP.
  • Precision & Specification Testing
    • Perform/oversee testing completed on all new and repaired refractometers
  • Calibration Verification Testing
    • Perform/oversee testing completed 6-months after Precision testing and semi-annually thereafter
  • Daily Control Verifications
    • Review daily controls for proper documentation and out of range refractometer performance trends.
  • Control Testing & Acceptance
    • Review for proper testing and acceptable control limits for refractometers.

Employee Performance (25%):

  • Review of Education Records
    • Ensure all staff have required High School Diploma or equivalent evidence on site to perform Moderate Complexity testing.
  • Direct Observations
    • Perform direct observations on staff trained in Donor Screening monthly and/or as needed, to include Moderate Complexity evaluations semi-annually.
  • Review of Center Personnel Licenses

Inspection Preparation and Management (25%):

  • Periodic Audit of all Moderate Complexity Records
    • Review, preparation and maintenance of Moderate Complexity records, ensuring retrievability during audits.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. 
  • Demonstrate work history of above average performance and attendance.
  • Excellent interpersonal skills and communication skills including written, verbal and oral presentations.
  • Result oriented with ability to adapt to changing priorities.
  • Attention to detail and organizational skills with analytical and problem solving skills.
  • Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.
  • Walking, standing, observing others performing work assignments. 
  • Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, leaning.
  • Ability to work in an office / production environment. 

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

  • Must be able to determine impact to product quality when testing deviations occur, contain the situation and implement preventive actions.

Interaction

  • Interfaces with employees of various educational backgrounds and levels within the company.  Must be able to communicate effectively with all these various business partners.

Innovation

  • May participate in the management of projects and new initiatives within the center or across centers.
  • 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).

Complexity

  • Travel to centers within the State of California is required. (Up to 75% of time)
  • May participate in the management of projects and new initiatives across centers.
  • Ability to stand up for 6-8 hours
  • Requires occasional bending, stooping, kneeling, crouching, leaning, reaching above shoulders and below knees, and ability to lift, carry and pull up to twenty-five (25) pounds
  • Potential exposure to blood borne pathogens requires some work tasks to be performed while wearing gloves.
  • The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Essential:

  • Bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and have at least 2 years of laboratory experience in moderate or high complexity testing.    
  • A current, California Clinical Laboratory Scientist License (CLS)

Desired:

  • 3 to 5 years’ experience in a professional or technical capacity in a laboratory, blood services, or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.
  • Familiarity with regulated disciplines in a blood bank setting or a pharmaceutical manufacturing environment.

ADDITIONAL INFORMATION

  • FLSA Classification (US) – 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.

Locations

California - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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1. Your Initial Application

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2. Your First Review

One of our Hiring Managers will review your application and reach out to you if we think you’re a good fit.

3. Your First Interview

We’ll arrange a time for us to meet virtually or in person. Depending on the role and market, there may be more than one interview.

4. Job Offer

If you’re successful in the interview process, we’ll get in touch with you to make a job offer.

5. Pre-Employment

After electronically accepting your offer, you’ll receive communications electronically which will guide you through the pre-employment process.

6. Onboarding

Once you complete the pre-employment process, we’ll arrange a date for you to join the team, with an onboarding session taking place in your first few weeks at the company.

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