Quality Specialist

4 weeks ago

Allentown, Pennsylvania, United States CSL Behring Full time

The Opportunity

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

Reporting compliance status data to operational quality managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The RolePerform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being usedCollaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues.Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers.Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective.Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.Follow all Standard Operating Procedures (SOPs), company policies and procedures.Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as 4-6 key responsibilities of the jobYour skills and experienceEducation High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred. ExperienceMinimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.Strong customer service skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to 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) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odorsOur Benefits CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit

About CSLPlasma

CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Plasma

  • Manager External Communications

    1 month ago

    Allentown, Pennsylvania, United States PPL Corporation Full time

    OverviewThe Manager - External Communications is an experienced communication professional responsible for developing and implementing communications plans that advance PPL's corporate reputation and strategic objectives. The incumbent provides strategic communications counsel to PPL executives and senior leaders and manages the company's brand to enhance...

  • Exteriors Specialist

    1 day ago

    Allentown, United States Holencik Exteriors Full time

    At **Holencik Exteriors** in Allentown, PA, we offer more than just a job - we provide a pathway to success. Join us as a **full-time E**xterior Specialist **to take your career to heights like never before! **WHAT'S IN IT FOR YOU?** **Industry-Leading Pay**: - Competitive salary of $80,000 - $150,000 per year with uncapped earning potential and a base...

  • Clinical Review Specialist

    3 weeks ago

    Allentown, United States The CKHobbie Group Full time

    Job DescriptionJob DescriptionThis is a remote position.The Clinical Review Specialist will be responsible for performing prospective, concurrent, or retrospective utilization review/medical management for all services provided by our organization. This role entails evaluating the appropriateness of care based on contract, state, or URAC requirements. They...

  • Reimbursement Specialist RCM

    3 weeks ago

    Allentown, United States Envision Staffing Solutions Full time

    Job DescriptionJob DescriptionFully Remote candidates wanted!Join Our Team as a Reimbursement Specialist: Are You Ready to Make a Difference?Are you passionate about navigating the complexities of billing and revenue cycle management? Are you ready to join a team dedicated to ensuring patients receive the care they need? If so, we have an exciting...

  • Capacity Modeling Specialist

    7 days ago

    Allentown, United States Sharp Services Inc Full time

    Capacity Modeling Specialist page is loaded Capacity Modeling Specialist Apply locations Allentown time type Full time posted on Posted 9 Days Ago job requisition id JR29503 SUMMARY: The Capacity Modeling Specialist leads the Supply Chain Capacity Modeling Process, in partnership with cross-functional Operations stakeholders, with responsibility for...

  • eMOC Process Management Specialist

    3 hours ago

    Allentown, United States Air Products Full time

    At Air Products, our purpose is to bring people together to reimagine what's possible, collaborate and innovate solutions to the world's most significant energy and environmental sustainability challenges. Grow with us as we embark on building tomorrow together by being the safest, most diverse and most profitable industrial gas company in the world. ...

  • Capacity Modeling Specialist

    7 days ago

    Allentown, United States Sharp Corporation Full time

    SUMMARY: The Capacity Modeling Specialist leads the Supply Chain Capacity Modeling Process, in partnership with cross-functional Operations stakeholders, with responsibility for supporting feasibility evaluations and strategic analysis. Creates and maintains complex models while ensuring accurate capacity is reflected based on a strong understanding of...

  • Retail Service Specialist

    2 days ago

    Allentown, United States American Automobile Association Full time

    Retail Service SpecialistWe are looking for someone who will thrive in a sales and service environment by cross-selling and upselling products. This is an exciting opportunity in our branch network and ideal for candidates interested in working in a teamwork environment with AAA members.Responsibilities include, but are not limited to:Greet all members and...

  • Service Specialist

    1 week ago

    Allentown, United States Paychex Full time

    Overview: Under a moderate level of guidance and direction, provides customer service for one or more Paychex products. Uses prescribed guidelines to ensure good customer relations are maintained and customer claims and complaints are resolved fairly, effectively and in accordance with Paychex policies and procedures. Builds knowledge of the organization,...

  • Service Specialist

    7 days ago

    Allentown, United States Paychex Full time

    Overview Under a moderate level of guidance and direction, provides customer service for one or more Paychex products. Uses prescribed guidelines to ensure good customer relations are maintained and customer claims and complaints are resolved fairly, effectively and in accordance with Paychex policies and procedures. Builds knowledge of the organization,...

  • Manufacturing Engineer

    3 days ago

    Allentown, United States FLSmidth & Co. AS Full time

    Manufacturing EngineerKey AccountabilitiesFocuses on designing, developing and implementing new or revised production processes for the efficient and economical mass production of goods including designing arrangement of manufacturing equipment to ensure most efficient and productive layout. This profile also covers Welding Specialists, being overall...

  • Undersea and Hyperbaric Medicine Full-Time position in Allentown, Pennsylvania

    1 month ago

    Allentown, United States St. Lukes University Health Network Full time

    **St. Luke’s University Health Network, the region’s largest, most established health system, a major teaching hospital, and one of the nation’s 100 Top Hospitals is seeking a Wound Care & Hyperbaric Medicine Physician.** This position will primarily be at our Sacred Heart Center in Allentown, PA but occasionally travel to all Wound Care Centers...

  • Wound Care Physician

    1 month ago

    Allentown, United States St. Luke’s University Health Network Full time

    St. Luke s University Health Network, the region s largest, most established health system, a major teaching hospital, and one of the nation s 100 Top Hospitals is seeking a Wound Care & Hyperbaric Medicine Physician. This position will primarily be at our Sacred Heart Center in Allentown, PA but occasionally travel to all Wound Care Centers throughout...

  • PT in Allentown, PA

    7 days ago

    Allentown, United States Health Providers Choice Full time

    DESCRIPTION PT PT Must have at least 2 years of recent experience in specialty applying for. American Heart Association BLS Certification is required. ACLS, PALS, TNCC, ENPC, NIHSS, etc. may also be required for some units (Career Placement Specialist will specify). PID: 270585 JOB BENEFITS PACKAGE Top Pay, Flexible Schedule, Great Benefits including: Blue...

  • OT in Allentown, PA

    1 day ago

    Allentown, United States Health Providers Choice Full time

    DESCRIPTION OT OT Must have at least 2 years of recent experience in specialty applying for. American Heart Association BLS Certification is required. ACLS, PALS, TNCC, ENPC, NIHSS, etc. may also be required for some units (Career Placement Specialist will specify). PID: 270609 JOB BENEFITS PACKAGE Top Pay, Flexible Schedule, Great Benefits including: Blue...

  • Tech Training

    2 weeks ago

    Allentown, United States PPL Full time

    Company Summary Statement : PPL Electric Utilities delivers safe, reliable and affordable electricity to more than 1.4 million homes and businesses throughout its 29-county service territory in eastern and central Pennsylvania. Through smart investments and innovation, it has built one of the most advanced electric grids in the United States. And, with over...

  • Manager External Communications

    1 month ago

    Allentown, United States PPL Corporation Full time

    Overview The Manager - External Communications is an experienced communication professional responsible for developing and implementing communications plans that advance PPL's corporate reputation and strategic objectives. The incumbent provides strategic communications counsel to PPL executives and...

  • Wound Care Physician

    1 month ago

    Allentown, United States St. Luke's University Health Network Full time

    St. Luke’s University Health Network, the region’s largest, most established health system, a major teaching hospital, and one of the nation’s 100 Top Hospitals is seeking a Wound Care & Hyperbaric Medicine Physician. This position will primarily be at our Sacred Heart Center in Allentown, PA but occasionally travel to all Wound Care Centers throughout...

  • Manager of Nutrition Services

    2 days ago

    Allentown, United States Fresenius Medical Care Full time

    PURPOSE AND SCOPE: Supports the delivery of excellent nutritional care to patients by providing supervision, training, direction, guidance and support to facility dietitians in an assigned area. Acts as a resource and subject matter expert to assist in the improvement of clinical quality outcomes. Acts as the liaison between dietitians and management in the...

  • Manager of Nutrition Services

    2 days ago

    Allentown, United States Fresenius Medical Care Full time

    PURPOSE AND SCOPE: Supports the delivery of excellent nutritional care to patients by providing supervision, training, direction, guidance and support to facility dietitians in an assigned area. Acts as a resource and subject matter expert to assist in the improvement of clinical quality outcomes. Acts as the liaison between dietitians and management in the...

  • Full Stack Java Developer

    2 weeks ago

    Allentown, United States The Social Station Full time

    We are a technology startup based in the Lehigh Valley, PA (Allentown area) with an opening for a Full Stack Java Developer. This is a full-time position based out of the Lehigh Valley.At The Social Station we are building the next generation social media marketing platform for agencies and brands. We develop native mobile applications, web-based tools, and...