Senior Technician 2, Quality Control

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Senior Technician 2, Quality Control: This position reports to our Minnetonka, MN office

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 we need innovative, strategic problem solvers who drive business results by adopting the collective attitude necessary to make our ONE TEAM culture thrive. We embrace open, honest and transparent communications to help us achieve collective win and we constantly strive to do more. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo and advancing our mission.

Join us as a Senior Technician 2, Quality Control 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 Senior Technician 2, Quality Control does the setup, troubleshooting and operation of manufacturing equipment and provides technical support throughout products lifecycle from product development through commercial production.

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

• Perform lot release testing, record data on data sheets and summarize, analyze, and perform basic statistical analysis on results when required.

• Perform receiving inspection activities on incoming materials which can include confirming specifications, performing visual examination and taking variable measurements, and rejecting and returning unacceptable materials.

• Provide independent, secondary peer review of fellow Technician’s work.

• Assemble sample product as needed for testing purposes.

• Document inspection results by completing reports, logs, and inputting data into databases.

• Monitor incoming product quality and report observations upward to Quality Engineering and/or Quality Management.

• Maintain measurement equipment in an operable state by following setup procedure and monitoring calibration status.

• Generate NCR/Deviation Reports.

• Develop and lead training exercises commensurate with area(s) of functional expertise.

• Support Internal Manufacturing activities.

• Provide leadership/mentorship to other members of the QC team, including training of new team members during onboarding.

To succeed in this role, you’ll need:

• Minimum High School degree with minimum 4 years of experience working in a quality control role with ISO and GMP systems requirements (an equivalent combination of experience and education may be considered)

• Ability to interface with technical services, R&D, manufacturing, and regulatory affairs to accomplish required tasks.

• Familiarity with Microsoft Excel and/or other spreadsheet/database software for compilation/trending of data.

• Knowledge of GxP, 21CFR, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance

• Strong background in a manufacturing and operations environment

• Sound technical background and the ability to educate stakeholders, management and customers pertaining to quality assurance/control principles and techniques.

• Ability to contribute engineering support to technical plans and reports.

• Strong knowledge of Good Documentation (GDP) and current Good Manufacturing (GMP) Practices required.

• Extensive experience with developing, validating, operating, and troubleshooting automated assembly and packaging/cartoning equipment.

• Experience in serialization and familiarity with Drug Supply Chain Security Act (DSCSA)

• Familiarity with Minitab preferred.

• Background in industrial controls and PLCs helpful

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

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