Quality Specialist Position Available In Seminole, Florida

Job Description:

The OpportunityThis position provides immediate support to theAssistant Manager of Quality in monitoring plasma center processesto ensure overall compliance with CSL Operating Procedures, as wellas all applicable local, state, federal requirements. This rolewill ensure compliance to training needs, SOPs, processes and otherregulatory or company directives are adhered in order to supportthe operations and quality requirements for businessoperations. Reporting compliance status data to operational qualitymanagement Collaborate with center management in the development andimplementation of continuous improvement plans Collaborate with Assistant Manager of Quality (AMQ), to be ableto represent the center during internal and external audits,responds to questions, and may stop operations, including shipmentsto address quality concerns Responsible for coordinating and managing training activities,policies and processes at the center level.

You will report to theAssistant Manager QualityThe Role Perform final QA review and release for all shipment andassociated documents, to ensure shipment meets customerspecifications. Ensure center records QA review to ensure thoroughness,accuracy and timeliness of required information. Initiateinvestigation and ensure documentation of regulatory deficiencies.

Determine the need for corrective action, ensure appropriatedocumentation and determine effectiveness of the action. Perform center records QA review to ensure thoroughness,accuracy and timeliness of required information. Initiateinvestigation and ensure documentation of regulatory deficiencies.

Determine the need for corrective action, ensure appropriatedocumentation and determine effectiveness of the action. Maintain and review Plasma center personnel training documentsto ensure documents comply with CSL procedures, SOP’s, CLIA/COLAand other applicable requirements. Maintain the Learning Management System to ensure dataintegrity, report generation and data analysis to comply withcompany and regulatory standards. Initiates schedule, coordinate and monitor the delivery of alltraining, such as new hire, annual and any retraining to meetcenter or other training and regulatory requirements. Ensure themost current version of training materials at the center is beingused Collaborates with center management when viewing the QualityManagement System to identify, coordinate and deliver retrainingfor the purpose of correcting or improving operational or qualityissues. Conduct periodic process assessments to ensure compliance ofCSL written procedures. Initiate investigation to ensuredocumentation of deficiencies and development of corrective actionplans, as necessary in partnership with management. Identifying and communicate non-conformities to CSL’s SOP’s. Inthe absence of the AQM, may conduct monthly quality team meeting toinform, promote, assess and identify opportunities for continuousprocess improvement in quality, safety, and training forimplementation. Promote Safety, Health and Environment Policies & Procedure.

Ensure safety training and safety practices are implemented andfollowed within the center. Conducts and may lead internal audits to monitor facilitycompliance with CSL procedures and policies, cGMP, OHSA, FDA, andother regulations, as applicable, and develop center responses fordeficiencies. In the absence of the AQM, host external auditsconducted by the regulatory agencies and customers. Responsible to initiate, investigate and close Trackwisereports in a timely manner. Confirm through follow-up, to ensureappropriate corrective action was initiated, implemented, andeffective. Maintain clean efficient work environment. Comply with allHealth Safety and Environmental (HSE) and Occupational Safety andHealth Administration (OSHA) policies and procedures. Conductroutine internal procedure and documentation audits, asapplicable. Follow all Standard Operating Procedures (SOPs), companypolicies and procedures. Comply with all local, state and federal regulations and lawsto include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA,HIPAA, and OSHA. Maintain confidentiality of all personnel, donor and centerinformation. Understand policies and procedures associated withhyperimmune programs at the center, if applicable. Assist Plasma center staff in completing other special projectsor assignments, as requested. Perform other job-related duties, as assigned.dd 4-6 keyresponsibilities of the jobYour skills and experienceEducationHighschool diploma or equivalent required. Associate or Bachelor’sdegree in business administration or biological sciencespreferred.

Experience Minimum 1-year leadership experience or equivalent of one-yearexperience in a regulated environment. Strong customer service skills Strong critical reasoning, decision-making and problem solvingskills to analyze situations Organizational skills and attention to details to handlemultiple tasks, short deadlines, frequent interruptions, andshifting priorities in support of changing company objectives Understand Quality Systems and/or regulated trainingrequirementsWorking Conditions(physical & mental requirements) Occasionally required to work with the public when they aredissatisfied 80% of the time standing and walking and 20% of the timesitting Reach, bend, kneel and have high level of manual dexterity See and speak with customers and observe equipmentoperation Occasionally be required to lift and carry 25 lbs. Exposure to hot and cold temperatures, sudden temperaturechanges, working with freezers and various odorsOur BenefitsCSLoffers the following benefits for this full-time position: Optionsfor health care benefits, including choices of plans for medical,dental, and vision, prescription drug coverage; Company-providedbasic life insurance and Short- and Long-Term Disability; theoption to participate in CSL’s 401(k) Savings Program; Paid TimeOff (PTO) for use in connection with vacations, illness, and otherpersonal business; and paid observed holidays as designated by theCompany. For more information on CSL Plasma benefits visithttps://cslbenefits.com/cslp.

About CSL PlasmaCSL Plasma is one ofthe world’s largest collectors of human plasma. Our work helps toensure that people with rare and serious diseases are able to livenormal, healthy lives. We are committed to our work because livesdepend on us. Learn more about CSL Plasma.

We want CSL to reflectthe world around usAs a global organization with employees in 35+countries, CSL embraces diversity and inclusion. Learn more aboutDiversity & Inclusion at CSL.Do work that matters at CSLPlasma!