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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 will inspire and empower you to grow through life-changing work.
We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, 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
Supervises Quality Assurance Coordinators and Quality Assurance Associates, to ensure that testing results, and laboratory quality operations follow 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 (CUA), and applicable Takeda and BioLife policies, and quality initiatives.
ACCOUNTABILITIES
- Hires, manages, plans, schedules, and evaluates the work of Quality Assurance Coordinators and QA Associates. Ensures that all inspection and test procedures are properly completed and documented. (20%)
- Reviews all quality assessment results and determines whether to accept or reject final test results. (10%)
- Works closely with Operations and Quality to ensure compliance with federal, state, local, and company-specific regulations related to quality of product and employee safety. (5%)
- Adheres to the laboratory quality control policies, documents all quality control activities, instrument and procedural calibrations, and maintenance performed. (5%)
- Identifies problems that may adversely affect test performance or reporting of test results and either correct the problems or immediately notify the laboratory management. (10%)
- Follow established corrective action policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance.
- Document all corrective actions taken when test systems deviate from established performance specifications.
- Ensure that test results are not reported until all corrective actions have been taken and the test system is properly functioning. (5%)
- 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 Map ping and Kaizen. (5%)
- Stays current with federal, state, local, and company-specific rules, regulations, and practices. (5%)
- Participates in audits of laboratory operations, documents audit findings, and reports results to Quality Managers and the Director of Operations. (5%)
- Conducts SOP training on new/revised Quality Assurance SOPs. (5%)
- Assists with the development and revision of Quality Assurance SOPs as needed. (5%)
- Assists the plasma collection centers with laboratory quality-related issues as needed. (5%)
- Reviews and approves final release of laboratory testing results (5%)
- Reviews and tracks Events and quality control data as required by Laboratory Quality SOPs. (5%)
- Participates in and provides the required data for Management Review Meetings and Quality Assurance Staff Meetings. (5%)
- Other duties as assigned.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Working knowledge of c-GMPs, laboratory operations, and testing procedures.
- Strong knowledge and understanding of applicable regulatory and quality requirements/standards.
- Strong written, verbal, and personal interaction and communication skills are required.
- Able to write concisely and clearly.
- Ability to articulate clearly and conduct presentations with success.
- Attention to detail and organizational skills with analytical and critical thinking skills.
- Proficiency in the use of personal computers and software programs, including Microsoft Word, Excel, and PowerPoint.
- Results-oriented with the ability to adapt to changing priorities.
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 the impact on 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.
Complexity
- Walking, standing, and observing others performing work assignments.
- Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, and leaning.
- Ability to work in an office/production environment.
- Occupational exposure to bloodborne pathogens.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential:
Bachelor's degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology) and at least 1 year of laboratory training or experience in high complexity testing.
OR
Associate degree from an accredited college/university in laboratory science or medical laboratory technology, and at least 2 years of laboratory training or experience in high complexity testing.
Desired:
- Bachelor's degree or higher from an accredited college/university in medical technology.
- Three to five years of professional or technical experience in a laboratory, blood services or pharmaceutical manufacturing, including significant exposure to the regulatory requirements for laboratory testing and release of final test results.
- Experience in supervising or training others is highly desirable.
- Prior experience with auditing and/or inspection processes preferred.
ADDITIONAL INFORMATION
- FLSA Classification (US) - Exempt
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 . T he 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 employee s may be eligible for s hort -t erm and/or l ong- t erm incentiv e s . 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
