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Quality Systems Specialist

Company: CSL Behring
Location: Boca Raton
Posted on: November 20, 2022

Job Description:

Job Description

  • Quality administration and oversight of the following:Review, and processing of all controlled document changes, as well as providing support with the document change process Records Management, including checking, tracking, and sending/retrieving records to/from off-site storage, and maintaining record inventories
  • Change control records as well as providing support with the change control processResponsibilities:-Processes document changes for all controlled documents utilizing the Document Management System to ensure all documents are revised, formatted and released consistently.-Reviews document changes to ensure compliance with cGMPs and CSL procedures. Communicates and coordinates with document authors and various departments to ensure document changes are completed and implemented based on established timelines.-Authors Document Control document changes, including initiating change requests, assessing risk of changes and approving the document changes.-Reviews Change Control records in the Change Control Management System. -Monitors electronic approval of records including record progression.-Provides customer service support to the facility for the Document Management and the Change Control Management Systems, including troubleshooting, usage, and best practices.-Provides a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.-Provides quality oversight of records management by reviewing and approving record inventories, schedules and tracks records sent to and from offsite storage, maintain record inventories, and assists in identifying records ready for destruction.-Assists Manager in identifying document control, change control and records management issues which need correction or improvement. Also assist Manager in preparing/conducting training, as requested.-Participates in department and company projects to continuously improve efficiency and quality. Identifies opportunities, develop strategies, gain consensus, test options, implement solutions, and communicate conclusions.-Facilitates Plasma change control process meetings including maintaining the change log, evaluating changes for content and risks identified and confirming changes can be scheduled for implementation. Publishes meeting minutes and ensures change actions identified in the meetings are managed appropriately.-Participate in internal and external audits, as required.-Perform other job-related duties as assigned.QualificationsEducation
    • Associates degree with 3-5 years' experience in a business setting or
    • High School diploma or equivalent with 3-5 years' experience in quality, manufacturing, or regulated industry, pharmaceutical preferredExperience
      • Experience in a highly regulated environment, such as the field of document control, change control, quality, pharmaceutical or manufacturing preferred
      • Has a working knowledge of cGMP principles and applications
      • Demonstrated ability to write and communicate technical information
      • Intermediate to strong working knowledge of Microsoft Office software suite and database application proficiency Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.About UsOur BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.About CSL PlasmaCSL 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 usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.Do work that matters at CSL Plasma!

Keywords: CSL Behring, Boca Raton , Quality Systems Specialist, Other , Boca Raton, Florida

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