Quality Specialist Position Available In Greater Bridgeport Planning Region, Connecticut

Job Description:

The Opportunity This 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 business operations.

Reporting compliance status data to operational quality managementCollaborate with center management in the development andimplementation of continuous improvement plans Collaborate withAssistant Manager of Quality (AMQ), to be able to represent thecenter during internal and external audits, responds to questions,and may stop operations, including shipments to address qualityconcerns Responsible for coordinating and managing trainingactivities, policies and processes at the center level. You willreport to the Assistant Manager Quality The Role Perform final QAreview and release for all shipment and associated documents, toensure shipment meets customer specifications. Ensure centerrecords QA review to ensure thoroughness, accuracy and timelinessof required information. Initiate investigation and ensuredocumentation of regulatory deficiencies. Determine the need forcorrective action, ensure appropriate documentation and determineeffectiveness of the action. Perform center records QA review toensure thoroughness, accuracy and timeliness of requiredinformation. Initiate investigation and ensure documentation ofregulatory deficiencies. Determine the need for corrective action,ensure appropriate documentation and determine effectiveness of theaction. Maintain and review Plasma center personnel trainingdocuments to ensure documents comply with CSL procedures, SOP’s,CLIA/COLA and other applicable requirements. Maintain the LearningManagement System to ensure data integrity, report generation anddata analysis to comply with company 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 complianceof CSL written procedures. Initiate investigation to ensuredocumentation of deficiencies and development of corrective actionplans, as necessary in partnership with management. Identifying andcommunicate non-conformities to CSL’s SOP’s. In the absence of theAQM, may conduct monthly quality team meeting to inform, promote,assess and identify opportunities for continuous processimprovement in quality, safety, and training for implementation.

Promote Safety, Health and Environment Policies & Procedure. Ensuresafety training and safety practices are implemented and followedwithin the center. Conducts and may lead internal audits to monitorfacility compliance with CSL procedures and policies, cGMP, OHSA,FDA, and other regulations, as applicable, and develop centerresponses for deficiencies. In the absence of the AQM, hostexternal audits conducted by the regulatory agencies and customers.

Responsible to initiate, investigate and close Trackwise reports ina timely manner. Confirm through follow-up, to ensure appropriatecorrective action was initiated, implemented, and effective.

Maintain clean efficient work environment. Comply with all HealthSafety and Environmental (HSE) and Occupational Safety and HealthAdministration (OSHA) policies and procedures. Conduct routineinternal procedure and documentation audits, as applicable. Followall Standard Operating Procedures (SOPs), company policies andprocedures. Comply with all local, state and federal regulationsand laws to include, but not limited to: ADA, Civil Rights, EEOC,FDA, GHA, HIPAA, and OSHA. Maintain confidentiality of allpersonnel, donor and center information. Understand policies andprocedures associated with hyperimmune programs at the center, ifapplicable. Assist Plasma center staff in completing other specialprojects or assignments, as requested. Perform other job-relatedduties, as assigned.dd 4-6 key responsibilities of the job Yourskills and experience Education High school diploma or equivalentrequired. Associate or Bachelor’s degree in business administrationor biological sciences preferred. Experience Minimum 1-yearleadership experience or equivalent of one-year experience in aregulated environment. Strong customer service skills Strongcritical reasoning, decision-making and problem solving skills toanalyze situations Organizational skills and attention to detailsto handle multiple tasks, short deadlines, frequent interruptions,and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirementsWorking Conditions (physical & mental requirements) Occasionallyrequired to work with the public when they are dissatisfied 80% ofthe time standing and walking and 20% of the time sitting Reach,bend, kneel and have high level of manual dexterity See and speakwith customers and observe equipment operation Occasionally berequired to lift and carry 25 lbs. Exposure to hot and coldtemperatures, sudden temperature changes, working with freezers andvarious odors Our Benefits CSL offers the following benefits forthis full-time position: Options for health care benefits,including choices of plans for medical, dental, and vision,prescription drug coverage; Company-provided basic life insuranceand Short- and Long-Term Disability; the option to participate inCSL’s 401(k) Savings Program; Paid Time Off (PTO) for use inconnection with vacations, illness, and other personal business;and paid observed holidays as designated by the Company. For moreinformation on CSL Plasma benefits visithttps://cslbenefits.com/cslp . About CSLPlasma CSL 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 us As a global organization with employees in 35countries, CSL embraces diversity and inclusion. Learn more aboutDiversity & Inclusion at CSL. Do work that matters at CSLPlasma!