Specialist 2, Quality-Complaints

4 weeks ago

Minnetonka, United States Halozyme Full time

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We look forward to discovering your talents.

Specialist 2, Quality-Complaints-Minnetonka, MN

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-Complaints 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

As a Specialist 2, Quality-Complaints for our Minnetonka, MN manufacturing site, you will coordinate activities associated with product quality complaint investigations. In this role, you will collaborate cross functionally to facilitate success by protecting patient/user safety.

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

  • Process commercial and clinical complaints received from the call center, health care providers, patients, and/or distributors.
  • Assess incoming product quality complaints, escalating potential issues and incidents to management
  • Coordinate with pertinent internal functional groups as needed to ensure timely investigation, root cause analysis, and closure of complaint records.
  • Evaluate complaint investigation results to ensure adherence to cGMP guidelines and expectations (including device and combination product cGMPs) in conjunction with technical and quality SMEs as appropriate.
  • Ensure internal and partnered complaint response timelines are being achieved and prepare detailed complaint reports.
  • Communicate adverse events reported in conjunction with Product Complaints to Antares PV Group
  • Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection/investigation.

To succeed in this role, you'll need:

  • BS degree in the Life Sciences with minimum 2 years of experience in product complaints and investigations (a combination of education and experience may be considered)
  • Strong computer skills. Proficiency with Microsoft Office business software and use of information databases. Fluency in Argus Database or other safety database is a plus.
  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
  • Ability to interface with internal customers, 3rd-party partners, HCPs and regulatory agencies
  • Customer Service oriented attitude and ability to exercise sound business judgment
  • Ability to maintain confidentiality and discretion in business relationships
  • Experience with post marketing surveillance and investigational experience a plus
  • Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus

In return, we offer you:

  • Hybrid work flexibility-requires 3 days weekly to work on site and more as needed
  • 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 $67K to $101K 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.

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.

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