Specialist 1, Quality
Specialist 1, Quality
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Job Description
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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. 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 1 Quality 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
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 Halozymes product lines under Good Manufacturing Practices (GMP) requirements and is pivotal to the execution of Halozymes product and program objectives and requires work contributions both individually and as part of a team.
In this role youll 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 youll need:
A bachelors 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 impacton 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 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:
Unclear Seniority
Employment Type
Full-Time
