Operations Laboratory Supervisor

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Job Description

About BioLife Plasma

Takeda offers 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. 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.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do. We foster an inclusive and collaborative workplace in which our teams are united by an unwavering commitment to bring Better Health and a brighter future to people around the world.

Every day, our BioLife Testing Laboratories' mission is to ensure the highest quality testing standards for the plasma we collect. The plasma our centers collect will become life-changing medicines for patients in need. Here, a commitment to lab testing quality, customer service to our plasma centers, and most importantly, our commitment to our patients is expected.

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

OBJECTIVES / PURPOSE

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.

ACCOUNTABILITIES

• Provides day-to-day supervision of all laboratory operations and moderate or high complexity testing performance in their laboratory area. (50%)
• Functions as a 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 the oversight of the Operations Manager and the CLIA Laboratory Director.
• Provides 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. (10%)
• 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.(5%)
• Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems. (10%)
• 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. (10%)
• Participates 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). (5%)
• Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Review testing, quality control, and other testing reports for accuracy, completeness, and compliance with requirements to ensure that quality standards, efficiency, and schedules are met (10%)
• Other duties as assigned.

The following are duties that may be designated by the CLIA Director to the General Supervisor :

The following are duties that may be designated by the CLIA Director to the Technical Supervisor or the Technical Consultant :

DIMENSIONS AND ASPECTS

Leadership

Decision Making and Autonomy

Complexity

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :

Essential :

Desired :

ADDITIONAL INFORMATION

BioLife Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location : USA - GA - Social Circle - Baxter Pkwy

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 - GA - Social Circle - Baxter Pkwy

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt Yes