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Job Description
The Laboratory Operations Supervisor is responsible for the operation of their laboratory area in accordance with 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 applicable Takeda and BioLife policies, procedures and quality initiatives.
Essential Functions
Responsibilities
Provides day-to-day supervision of all laboratory operations and moderate or high complexity testing performance in their laboratory area.
Functions as supervisor for testing personnel performing high and moderate complexity testing. Organize and prioritize workloads and assignments in conjunction with donor center requirements.
Responsible for maintaining reagent and consumable inventory.
Performs annual employee performance reviews and employee counseling. Performs and reviews pre-analytical staff training and competency assessments. Ensures proper training is received under oversight of Operations Manager and CLIA Laboratory Director.
Provide technical assistance to staff, operations, and donor centers in laboratory related issues
Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor.
Performs NCMR, ENC and CAPA functions.
Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance. Participates in the evaluation of new tests and methodologies.
Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems.
Ensures periodic review of SOPs is performed and changes are implemented in a timely manner. Ensures that all procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines.
Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence goals (including but not limited to 5S, Value Stream Mapping, Kaizen, Layered Standardized Gemba Walks).
Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Reviews testing, quality control, and other testing reports for accuracy, completeness and compliance to requirements to ensure that quality standards, efficiency, and schedules are met.
Other duties as assigned.
Education & Experience Requirements
OR
Desired:
Bachelor’s degree or higher from an accredited college/university in medical technology
Previous supervisory experience in a laboratory setting preferred
MT or MLT certification from ASCP or other accredited certifying organization preferred
Key Skills and Competencies
Takeda has maintained an unwavering dedication to put patients first for more than 235 years while we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
We focus our research and development on the core therapeutic areas of oncology, gastroenterology, neuroscience, and on providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
BioLife, a subsidiary of Takeda, is an industry leader in operating high quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone. BioLife’s employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off, on the job training, advancement potential AND an environment full of fast-paced fun all while working to save lives.
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.
Ability of Walking, standing, observing others performing work assignments.
Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, leaning.
Occupational exposure to blood borne pathogens.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Other Job Components
Complexity and Problem Solving
Internal and External Contacts
Other Requirements
Ability to stand up for 6-8 hours
Ability to lift, carry and pull up to twenty-five (25) pounds
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - AL - Hoover
U.S. Base Salary Range:
$86,500.00 - $135,960.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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
USA - AL - Hoover
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes