Specialist 1, Quality

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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. 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 1, Quality, 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

This Specialist 1, Quality supports the Quality Disposition Team (QDT). This role is principally responsible for review of batch records and associated documentation in support of the disposition of Halozyme's product lines under Good Manufacturing Practices (GMP) requirements and is pivotal to the execution of Halozyme's product and program objectives and requires work contributions both individually and as part of a team.

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

• Review Executed Batch Records and completion of batch disposition activities (including generation of associated release documentation and certifications, etc.)

• Ensure compliance with GMP, Good Documentation Practices (GDP), regulatory and partner requirements as well as any other applicable industry standards

• Communicate with Contract Development and Manufacturing Organizations (CDMOs) and Drug Substance core internal and external teams and project management

• Engage and collaborate with Quality Assurance oversight personnel responsible for oversight of CDMO manufacture on a routine basis

• Coordinate with Supply Chain team in disposition efforts with third party logistics supplier (e.g., provision of supporting data or information)

• Ensure product is stored and transported to appropriate temperature conditions via validated or qualified shipper

• Assist with maintaining file organization within the Quality department

• Follow all corporate and departmental policies and procedures affecting Quality Assurance

To succeed in this role, you'll need:

• A bachelor's degree is required with a minimum of 1 year in a GMP/21CFR211 compliant environment (An equivalent combination of education and experience may be considered)

• Professional work experience in one of the following fields is required: biologics, pharmaceutical, device, diagnostic or medical

• Some knowledge and understanding of GMPs and GDP requirements and general familiarity with GLPs and GCPs

• Experience with a Quality Management System (QMS) such as MasterControl or Veeva is preferred

• Effective verbal and written communication skills, and ability to effectively interact with employees in a team-based environment

• Proficiency in standard applications of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) is required; experience with SharePoint, DocuSign or SmartSheet is 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 $61K - $85K 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 hrbox@halozyme.com.

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