Specialist 2, Quality Systems

Position Summary

The Quality Systems Specialist 2 is responsible for the administration and maintenance of the document and record management processes. They maintain the Quality Management System (QMS) document and records archived by Halozyme. They support the training program activities for Halozyme. They participate and facilitate the change control process as it pertains to the eQMS process.

Essential Functions And Responsibilities

• Facilitate timely processing of new documents, document changes and change controls.
• Covers coordination with internal functional groups as needed.
• Reviews internal documents prior to issuance to confirm compliance with Halozyme standards and works with document owners to resolve deficiencies.
• Maintains QMS record storage, including organization and retrieval of records stored by Halozyme.
• Leads review of retained records for transfer to off-site storage locations or disposal as required.
• Supports processing of Change Controls, as needed.
• As the Subject SME, delivers training to employees on the use of eQMS for document control, change control, and other systems as needed.
• Enters and maintains data contained within the Enterprise Resource Planning (ERP) software system.
• Prepares and reports quality metrics related to document control and other processes as needed.
• Supports the administration of the electronic Quality Management System software.
• Generates reports for management and inspections, as requested.
• Supports audits (internal, client, due diligence, regulatory) as needed for document requests related to document control and training processes.
• Supports validation and version upgrade activities for eQMS, LMS, and Enterprise Resource Planning (ERP) software, as needed.
• Training Program Support:
  • Affords assistance to training program activities as they pertain to the eQMS and document management process.
  • Provides input to support the continual improvement of document control, record management, and training processes.
• Maintains a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Education, Experience, Knowledge, Skills And Abilities

• Minimum two years of college or work experience equivalent.
• Three or more years in medical device or pharmaceutical document management, change control management, and training administration systems.
• An equivalent combination of experience and education may be considered.
• Strong computer skills.
• Familiarity with Microsoft Office business software and use of information databases, particularly Microsoft Word, PowerPoint, and Excel.
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance.
• Experience with eQMS software for document and record management and training.
• Knowledge of ComplianceWire and/or MasterControl a plus.
• Proven ability to communicate effectively; orally and written.
• Ability to manage multiple tasks and projects, using negotiation skills to push tasks to completion.
• Ability to prioritize workload to meet deadlines and to maintain high levels of quality and accuracy.
• Able to work independently, as well as in a cross-functional team environment.
• Customer Service oriented attitude and ability to exercise sound business judgment.