Specialist 2, Quality Systems

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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 a Specialist 2, 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 Specialist 2, Quality Systems administers and maintains the document and record management processes. They also maintain the Quality Management System (QMS) document and records archived and support the training program activities for Halozyme. They participate and facilitate the change control process as it pertains to the eQMS process.

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

• Facilitate timely processing of new documents, document changes and change controls.

• Reviews internal documents prior to issuance to confirm compliance with Halozyme standards and works with document owners to resolve deficiencies.

• Manages periodic document review process at Halozyme facilities.

• Maintains QMS record storage, including organization and retrieval of records stored by Haloyme. Leads review of retained records for transfer to off-site storage locations or disposal as required.

• 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.

• Generates reports for management and inspections, as requested.

• Supports audits (internal, client, due diligence, regulatory) for document requests related to document control and training processes.

• Supports administration, validation and version upgrade activities for eQMS, LMS, and Enterprise Resource Planning (ERP) software, as needed.

• Assist 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.

• Performs duties in accordance with the Company’s QMS and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.

To succeed in this role, you’ll need:

• Minimum two years of college or work experience equivalent.

• 3 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 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.

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.

The most likely base pay range for this position is $71K - $100K per year. 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.

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.

Accessibility and Reasonable Accommodations:

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 [email protected].

To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here.