Specialist , Quality Systems

Quality Systems Specialist 2 – Halozyme

Location:

Minnetonka, MN

• Facilitate timely processing of new documents, document changes, and change controls.
• Coordinate with internal functional groups as needed.
• Review internal documents prior to issuance to confirm compliance with Halozyme standards and resolve deficiencies with document owners.
• Manage the periodic document review process at Halozyme facilities.
• Maintain QMS record storage, including organization and retrieval of records stored by Halozyme.
• Lead review of retained records for transfer to off‑site storage locations or disposal as required.
• Support processing of change controls as needed.
• Deliver training to employees on the use of eQMS for document control, change control, and other systems as the Subject SME.
• Enter and maintain data within the Enterprise Resource Planning (ERP) software system.
• Prepare and report quality metrics related to document control and other processes as needed.
• Support the administration of the electronic Quality Management System software.
• Generate reports for management and inspections upon request.
• Support audits (internal, client, due diligence, regulatory) as needed for document requests related to document control and training processes.
• Support validation and version upgrade activities for eQMS, LMS, and ERP software as needed.
• Assist training program activities pertaining to the eQMS and document management process.
• Provide input to support continual improvement of document control, record management, and training processes.
• Perform duties in accordance with the Company’s QMS and with SOPs that are consistent with regulatory requirements and industry standards.
• Maintain a strong collaborative partnership with cross‑functional team members to facilitate organizational success by protecting patient/user safety and meeting business needs.
• Perform other related duties as assigned by the manager.

• 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.
• Fluent in Microsoft Office business software and 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 Compliance Wire and/or Master Control is a plus.
• Proven ability to communicate effectively, orally and in writing.
• Ability to manage multiple tasks and projects, using negotiation skills to push tasks to completion.
• Ability to prioritize workload to meet deadlines while maintaining high levels of quality and accuracy.
• Ability to work independently as well as in a cross‑functional team environment.
• Customer service oriented attitude and ability to exercise sound business judgment.

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development, and progression through in‑house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact on your career, the work you do, and patients’ lives.

The most likely base pay range for this position is $71K – $105K per year, with additional compensation potential through bonuses, sales incentives, and equity awards.

Halozyme, Inc. is an equal employment opportunity employer. We provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process.