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Senior Specialist 1, Quality Systems

Welcome to an inspired career.

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team - we rise by lifting others up and believe in the power of working together for the collective win. That's why we need you-to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.

Join us as Senior Specialist 1, Quality Systems and you'll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's lives.

How you will make an impact

The Senior Specialist 1, Quality Systems does overall administration and maintenance of the document control and records management program areas. They maintain the Quality Management System (QMS) document and records archived by Halozyme and work on the development and implementation of improved document and records processes. In this role, you will ensure processes associated with the document and records areas comply with internal and external regulations, procedures, and standards. You will also support the training program activities for Halozyme.

In this role, you'll have the opportunity to:

• Maintain oversight of the document management and record management program areas.
• Lead initiatives involving document and record management improvements.
• Facilitate timely processing of new documents, document changes and change controls.
  • Review internal documents prior to issuance to confirm compliance with Halozyme standards and work with document owners to resolve deficiencies.
  • Manage the periodic document review and revision process at Halozyme facilities.
  • Maintain QMS record storage, including organization and retrieval of records stored and lead review of retained records for transfer to off-site storage locations or disposal as required.
• Provide support and training to employees on the use of eQMS for document management and other systems as needed.
• Identify continuous improvement areas in document management, record management, and training.
• Generate quality metrics and reports related to documents, records, and training for management, as requested.
• Support audits (internal, client, due diligence, regulatory) as needed for document requests or reports related to document control, records management, and training processes.
• Support validation and version upgrade activities for eQMS, LMS, and Enterprise Resource Planning (ERP) software, as needed.
• Enter and maintain data contained within the Enterprise Resource Planning (ERP) software system.
• Support training program activities within the Quality Management System:

To succeed in this role, you'll need:

• Bachelor's Degree in business, science, technical field with minimum of 5 years experience working in medical device or pharmaceutical industry document management and training administration systems (a combination of education and experience may be considered)
• Strong computer skills. Advanced level knowledge of Microsoft Office business software and use, particularly Microsoft Word, Visio, PowerPoint, and Excel.
• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance.
• Experience with eQMS software(s) for document management, record management, and training. Knowledge and experience with ComplianceWire and/or MasterControl required.
• Ability to train and educate stakeholders, partners, and management

In return, we offer you:

• 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.

Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to 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.

The most likely base pay range for this position is $86,200K - $129,400K annually. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.

AccessibilityandReasonableAccommodations:
Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at hrbox@halozyme.com.