Specialist 2, Quality Systems

Save time and apply through your LinkedIn account. Click the button and your LinkedIn profile will be imported into our site.

In order to move forward you will need to create an account. Your password must be eight characters long contain at least one special character one capital letter and a number.

We look forward to discovering your talents.

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. Thats why we need youto 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 youll be part of a culture that welcomes diversity thinks differently to solve problems works collaboratively as one team and delivers meaningful innovations that impact peoples 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 youll 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 Companys QMS and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.

To succeed in this role youll 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 impacton 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 individuals 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 .

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

Required Experience :

IC

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 71 - 100