Clinical Laboratory Scientist, CLS
Company: Biolife Plasma Services
Location: Stockton
Posted on: June 15, 2022
Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAbout BioLife Plasma
ServicesEvery 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 OffOBJECTIVES/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 LicensesInspection 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 businessDecision-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
StatementTakeda 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.LocationsCalifornia - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Biolife Plasma Services, Stockton , Clinical Laboratory Scientist, CLS, Healthcare , Stockton, California
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