Lab Quality Coordinator – 2nd Shift Position Available In Ouachita, Louisiana

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge.

Job Description About Us:

Every day,our BioLife Testing Laboratories’ mission is to ensure the highestquality testing standards for the plasma we collect. The plasma ourcenters collect will become life-changing medicines for patients inneed. Here, a commitment to lab testing quality, customer serviceto our centers and most importantly our commitment to our patientsis expected. BioLife Plasma Services is a subsidiary of TakedaPharmaceutical Company Ltd.

What Takeda can offer you:

Takedaoffers a purpose you can believe in, a team you can count on,opportunities for career growth, and a comprehensive benefitsprogram, all in a fast-paced, friendly environment. Every day atBioLife, we feel good knowing that what we do helps improve thelives of patients with rare diseases. While you focus on ourdonors, we’ll support you.

More about us:

At Takeda, we aretransforming patient care through the development of novelspecialty pharmaceuticals and best in class patient supportprograms. Takeda is a patient-focused company that will inspire andempower you to grow through life-changing work. Certified as aGlobal Top Employer, Takeda offers stimulating careers, encouragesinnovation, and strives for excellence in everything we do. Wefoster an inclusive, collaborative workplace, in which our teamsare united by an unwavering commitment to bring Better Health and aBrighter Future to people around the world.

Role Overview:

Responsible for the operation of the laboratory in accordance withestablished Standard Operating Procedures (SOPs), applicablesections of the Code of Federal Regulations (CFRs), with emphasison Good Manufacturing Practices (GMPs), the Clinical LaboratoryImprovement Act of 1988 (CLIA), and applicable Takeda and BioLifepolicies, procedures and quality initiatives. Performs qualityassurance activities of BioLife Testing laboratory by performingthe following duties.

ACCOUNTABILITIES

Reviews testing, qualitycontrol, and other testing reports for accuracy, completeness andcompliance to cGMP requirements to ensure that quality assurancestandards and regulatory requirements are met prior to release fromthe Quality Assurance Department. Maintains familiarity withlaboratory operating and quality assurance/quality controlprocedures and quality system processes in order to effectivelyperform laboratory quality assurance functions. Adheres to thelaboratory quality control policies, document all quality controlactivities, instrument and procedural calibrations and maintenanceperformed. Identifies problems that may adversely affect testperformance or reporting of test results and either correct theproblems or immediately notify the laboratory management. Followestablished corrective action policies and procedures whenever testsystems are not within established acceptable levels ofperformance. Document all corrective actions taken when testsystems deviate from established performance specifications.

Performs review and or validation of SOPs as needed. Participatesin operational excellence initiatives and projects to drive aculture of continuous improvement to achieve site operationalexcellence goals (including but not limited to 5S, Value StreamMapping, and Kaizen. Other duties as assigned. Technical/Functional(Line) Expertise Strong knowledge and understanding of applicableregulatory and quality requirements and standards. Strong written,verbal, personal interaction and communication skills required.

Must be able to write concisely and clearly. Attention to detailand organizational skills with analytical and problem solvingskills. Proficiency in the use of personal computers and softwareprograms including Microsoft Word, Excel and PowerPoint. Resultoriented with ability to adapt to changing priorities. LeadershipIntegrity Fairness Honesty Perseverance Putting the patient at thecenter Building trust with society Reinforcing our reputationDeveloping the business Decision-making and Autonomy Must be ableto determine impact to product quality when testing deviationsoccur, contain the situation and implement preventive actions.

Interaction Interfaces with employees of various educationalbackgrounds and levels within the company. Must be able tocommunicate effectively with all these various business partners.

Complexity Ability to stand up for 6-8 hours Ability to lift, carryand pull up to twenty-five (25) pounds Walking, standing, observingothers performing work assignments. Potential exposure to bloodborne pathogens requires some work tasks to be performed whilewearing gloves. Ability to work in an office / productionenvironment. The physical demands described above arerepresentative of those that must be met by an employee tosuccessfully perform the essential functions of this job.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Bachelor’s degreeor higher from an accredited college/university in a biomedicaldiscipline (Chemical, physical, biological, clinical lab science,or medical technology,) OR Associate degree from an accreditedcollege/university in laboratory science or medical laboratorytechnology.

Desired:

Minimum of two years’ experience in aprofessional or technical capacity in laboratory services, bloodservices, quality, or pharmaceutical manufacturing, includingsignificant exposure to the regulatory requirements affecting thatdiscipline or activity. Technical/Professional certificationpreferred. Prior experience with auditing and/or inspectionprocesses preferred. MT or MLT certification from ASCP or otheraccredited certifying organization preferred BioLife Compensationand Benefits Summary We understand compensation is an importantfactor as you consider the next step in your career. W e arecommitted to equitable pay for all employees, and we strive to bemore transparent with our pay practices.

For Location:

USA

• GA•Social Circle•Baxter Pkwy U.

S.

Hourly Wage Range:

$18.85

• $29.

62The estimated hourly wage range reflects an anticipated range forthis position. The actual hourly wage offered may depend on avariety of factors, including the qualifications of the individualapplicant for the position, years of relevant experience, specificand unique skills, level of education attained , certifications orother professional licenses held, and the location in which theapplicant lives and/or from which they will be performing the job.

The actual hourly wage offered will be in accordance with state orlocal minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. basedemployees may be eligible to participate in medical, dental, visioninsurance, a 401(k) plan and company match, short-term andlong-term disability coverage, basic life insurance, a tuitionreimbursement program, paid volunteer time off, company holidays,and well-being benefits, among others. U.S. based employees arealso eligible to receive, per calendar year, up to 80 hours of sicktime, and new hires are eligible to accrue up to 120 hours of paidvacation. EEO Statement Takeda is proud in its commitment tocreating a diverse workforce and providing equal employmentopportunities to all employees and applicants for employmentwithout regard to race, color, religion, sex, sexual orientation,gender identity, gender expression, parental status, nationalorigin, age, disability, citizenship status, genetic information orcharacteristics, marital status, status as a Vietnam era veteran,special disabled veteran, or other protected veteran in accordancewith applicable federal, state and local laws, and any othercharacteristic protected by law. Locations USA

• GA•Social Circle•Baxter Pkwy Worker Type Employee Worker Sub-Type Regular TimeType Full time Job Exempt No