Quality Coordinator (Plasma Quality Release) 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 Job Description Thisrole is responsible for reviewing documentation associated withplasma receipt and dispositioning, as well as release of acceptableplasma to production. Additional quality oversight is provided forPlasma Operations activities. This position is also responsible forprocessing Post Donation (PDI) received from Plasma Suppliers andTesting Laboratories, to ensure the appropriate Category isassigned to the Notification/Observation and to ensure the plasmaunits in inventory are flagged for destruction. Plasma ReleaseReview documentation associated with plasma dispositioning andperform quality review and release for plasma to be used inTeardown in the Automated Plasma Dispositioning System (APDS).Review shipment documentation associated with plasma shipmentsreceived and perform quality review in the Automated PlasmaDispositioning System (APDS). Ensure destruction of unsuitableplasma units, as necessary and ensure proper documentation: performrequired system transactions. Place shipments and plasma centers onhold and remove holds based on sufficient support documentation andapprovals. Lookback Process and/or verify Lookback/PDINotifications/Observations received from plasma suppliers withinthe timeframe specified in department procedures and incompliancewith regulatory requirements. Quality System Initiate Deviations inTrackwise for internal discrepancies associated with Plasma QualityRelease and Plasma Operations processes and for plasma supplierdiscrepancies; conduct investigations and identifycorrective/preventative actions. Review and ensure discrepanciesare documented, investigated, and resolved using the appropriatePQR Quality System according to set deadlines. Revise departmentowned procedures for compliance with Corporate, BioLife, andRegulatory requirements and implementation of continuousimprovement initiatives as required. Utilize excellent grammar,mechanics and proofreading skills to generate clear, concise, andaccurate documentation (e.g. NCE, Deviations, SCAR formalmemorandums, electronic mail, etc.) Conduct process audits toensure activities and documentation conform to standard operatingprocedures and regulatory requirements. File documentationaccording to procedural requirements and ensure retention policiesare met. Other Identify, lead and implement continuous improvementprojects. Actively participate in internal or external audits asrequired (e.g. runner, communication flow, document reviewer, etc.)and support the closure of audit observations within the specifiedtimeframe. Support special projects / protocols execution. Identifyand inform PQR Management of plasma related discrepancies.

Communicate with quality, manufacturing, technical support groups,and plasma supplier staff to ensure availability of plasma and toresolve plasma related discrepancies. Provide and present tomanagement monthly statistical data for key metrics, such as plasmareceipts, plasma on hold and other key information. Create andpresent PowerPoint slides for the purposes of presenting data, asrequired. Other duties as assigned Technical/Functional (Line)Expertise Must possess effective interpersonal, communication,leadership, influencing, and Negotiating skills to interact withall laboratories and suppliers on a frequent basis. Strongknowledge and understanding of applicable regulatory and qualityrequirements and standards. Must be able to write concisely andclearly. Ability to articulate clearly and conduct oralpresentations. Attention to detail and organizational skills withanalytical and problem-solving skills. Proficiency in the use ofpersonal computers and software programs including Microsoft Word,Excel and PowerPoint. Result-oriented with the ability to adapt tochanging priorities. Demonstrated ability to convey technicalinformation to others. Must have the ability to act as a changeagent to identify and implement solutions as well as effectivelylead and motivate team members to achieve team goals Strongorganizational skills and the ability to prioritize workflow,handle multiple activities, and meet deadlines as set. Ability tocomplete tasks by following guidelines, procedures and policies.

Knowledge of FDA Regulations (cGMP, GDP, etc.) as they apply toBiologics. Self-directed and motivated to complete complex tasksand make quality decisions. Leadership Living our leadershipbehaviors is a basic expectation for all Takeda employees. Takedaexpects all employees to embody the following: Leadership BehaviorsIntegrity Fairness Honesty Perseverance Critical Skills Attentionto detail. Strong organizational skills and the ability toprioritize workflow, handle multiple activities, and meet deadlinesas set. Ability to complete tasks by following guidelines,procedures and policies. Knowledge of FDA Regulations (cGMP, GDP,etc.) as they apply to Biologics. Self-directed and motivated tocomplete repetitive tasks, with sensitivity to confidentialinformation. Excellent writing skills and verbal communicationskills. Ability to diplomatically interact well with coworkers,cross-functional team members, internal and external customers.

Must be a team player. Ability to provide training and guidance toother team members Interaction Ability to diplomatically interactwell with coworkers, cross-functional team members, internal andexternal customers. Plasma Operations Group

• provides qualityoversight and advise. Plasma Suppliers and Service Providers
• effectively communicate and work with suppliers to resolve anyissues in a timely manner. BioLife HQ Quality Systems
• coordinateactivities pertaining to management of temperature excursions,supplier/service provider’s discrepancies, advance notificationsand other quality and logistics related activities.

ComplexityAbility to identify errors, non-conformances, or deficiencies andprovide guidance to Plasma Operations and Plasma Quality Release.

Identify faults/gaps in the process using problem-solving tools(e.g., Brainstorming, FMEA, etc.) and recommend and/or implementsolutions. Communicate to management issues and recommend/proposingsolutions.

Essential:

BA / BS degree in Life Sciences and/orBusiness required or equivalent experience. Proficient/Intermediateknowledge of Microsoft Office (Word, Excel, Visio, and PowerPoint).

Desired:

2

• 4 years of experience in Plasma / Whole Blood Industryor Biopharmaceutical / Biotech. 1
• 2 years of experience in thequality organization.

Knowledge of computerized systems (e.g. APDS,TrackWise, C3ME, LIMS) or other inventory management or qualitysystems software.

ADDITIONAL INFORMATION

Must be able to lift,push, pull and carry up to 50 lbs. The position requires acombination of sedentary work and walking around observingconditions in the facility. Must be able to work in coldtemperature conditions ranging from

• 28°C-8°C Must be able to wearspecial personal protective equipment required in cold environmentsover the head, face, hands, feet and body.

Must be able tosit/stand for prolonged period of time. Some walking across thefacility between various plasma management areas is necessary,including use of stairs. Must be able to work multiple shifts,including weekends. Must be able to work overtime as required.

BioLife Compensation and Benefits Summary We understandcompensation is an important factor as you consider the next stepin your career. W e are committed to equitable pay for allemployees, and we strive to be more transparent with our paypractices.

For Location:

USA

• GA•Social Circle•Baxter PkwyU.

S.

Hourly Wage Range:

$20.53

• $32.

26 The estimated hourly wagerange reflects an anticipated range for this position. The actualhourly wage offered may depend on a variety of factors, includingthe qualifications of the individual applicant for the position,years of relevant experience, specific and unique skills, level ofeducation attained , certifications or other professional licensesheld, and the location in which the applicant lives and/or fromwhich they will be performing the job. The actual hourly wageoffered will be in accordance with state or local minimum wagerequirements for the job location. U.S. based e mployees may beeligible for short-term incentives. U.S. based employees may beeligible to participate in medical, dental, vision insurance, a401(k) plan and company match, short-term and long-term disabilitycoverage, 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 areeligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforceand providing equal employment opportunities to all employees andapplicants for employment without regard to race, color, religion,sex, sexual orientation, gender identity, gender expression,parental status, national origin, age, disability, citizenshipstatus, genetic information or characteristics, marital status,status as a Vietnam era veteran, special disabled veteran, or otherprotected veteran in accordance with applicable federal, state andlocal laws, and any other characteristic protected by law.

Locations USA

• GA•Social Circle•Baxter Pkwy Worker TypeEmployee Worker Sub-Type Regular Time Type Full time Job ExemptNo