Sr. Quality Associate II / Principal Quality Associate, Quality Compliance

GRIFOLS, S.A.-posted 3 days ago
Full-time • Mid Level
Onsite • Clayton, NC
101-250 employees
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The Clayton Grifols Quality Compliance department provides leadership to support cGMP compliance of the large and dynamic multi-facility Clayton North Carolina campus. The North Carolina campus performs fractionation of blood plasma, purification, aseptic filling, lyophilization, final packaging, and warehousing of plasma related products. The Principle Quality Compliance Associate will support hosting external audits and will support and lead quality compliance and site initiatives for process improvement. The incumbent is a professional with high technical competency who leads project or discipline teams. The employee influences the direction of complex projects and communicates with all levels of personnel. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee is a fully qualified professional who requires minimal supervision. Interactions by this position include collaboration within the GT Clayton site, other Grifols BioPharma sites, suppliers/customers, and/or regulatory agencies. As appropriate, this employee may serve as delegate to the department manager. Depending on background and the level of experience, this position may also be filled as a Sr. Quality Associate I or II.

  • Use expertise to advise and influence the technical decisions of business units
  • Demonstrates the ability to influence the decision makers in other departments
  • Has excellent communication skills (written and verbal) with demonstrated use of domestic (i.e. Food and Drug Administration CFR) and applicable foreign regulatory agency requirements/guidelines
  • Interacts regularly with members of management and as needed with regulatory officials
  • Leads multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion
  • May serve as manager delegate with demonstrated experience in Quality Systems and with GT products/processes
  • Prepares, organizes, and tracks documentation and requests in support of regulatory and customer audits
  • Authors, reviews, and revises responses to regulatory and customer audits
  • Coordinates and manages logistics of on site and remote regulatory and customer audits
  • Track and follow-up on audit commitments and corrective actions
  • Perform effectiveness checks for audit related corrective actions
  • Author Quality Agreements for Grifols Suppliers and Customers
  • Author Biological Product Deviation Reports
  • Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply
  • Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Risk Assessments, Incident Tracking System entries and investigation reports
  • Revise / update and coordinate executive management review of the Grifols Clayton site master file
  • Manages and provides audit history information to internal customers
  • Compiles department metrics
  • Tracks corrective action resolution for near hit observations identified by management during regulatory or customer audits
  • Partners with stakeholders to identify and implement continuous improvement solutions with demonstrated / measured business results
  • Provides support to other functions within the Quality Compliance group
  • Provides guidance and training for other employees
  • Knowledge of domestic and foreign regulatory authority requirements
  • Investigation skills with nonconformances including root cause analysis and corrective/preventive actions
  • Excellent organizational skills and the ability to follow up on matters consistently and diligently until timely resolution is achieved
  • Demonstrated ability to consistently apply technical knowledge in making sound quality decisions with minimal guidance
  • Technical report writing skills with the ability to produce high quality documentation appropriate for the intended audience
  • Ability to think critically/strategically and act proactively
  • Demonstrates integrity and company values
  • Follows cGMP and departmental safety practices
  • Knowledge and experience using Microsoft Office applications
  • Sr. Quality Associate I, Quality Compliance:  BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.
  • Sr. Quality Associate II, Quality Compliance: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience.
  • Principal Quality Associate, Quality Compliance: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS degree is required.
  • SAP Quality Module
  • Strong Excel skills, familiarity with pivot tables
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