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QA Lead Testing Coordinator - Covington, GA, United States - Biolife Plasma Services
Description
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use .
I further attest that all information I submit in my employment application is true to the best of my knowledge.
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 centers and most importantly our commitment to our patients is expected.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.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.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives 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.
Responsible for the operation of the laboratory 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.
Reviews testing, quality control, and other testing reports for accuracy, completeness and compliance to cGMP requirements to ensure that quality assurance standards and regulatory requirements are met prior to release from the Quality Assurance Department.
~ Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system processes in order to effectively perform laboratory quality assurance functions.~ Adheres to the laboratory quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.
Identifies problems that may adversely affect test performance or reporting of test results and either correct the problems or immediately notify the laboratory management.
Follow established corrective action policies and procedures whenever test systems are not within established acceptable levels of performance.Document all corrective actions taken when test systems deviate from established performance specifications.
~ 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, and Kaizen.
~ Strong knowledge and understanding of applicable regulatory and quality requirements and standards.
Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.
Building trust with society
Must be able to determine impact to product quality when testing deviations occur, contain the situation and implement preventive actions.
Ability to work in an office / production environment.Bachelor's degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology,)
Associate degree from an accredited college/university in laboratory science or medical laboratory technology.
Minimum of two years' experience in a professional or technical capacity in laboratory services, blood services, quality, or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.
Hourly Wage Range:
$The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
S. based e mployees may be eligible for short-term incentives. 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.
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.
Full time