Quality Control Systems Specialist

2 days ago


Durham, North Carolina, United States Biogen Full time
About This Role

This is a full-time, on-site position with Monday to Friday business hours. As a Biogen team member, you will have the opportunity to work in a dynamic and innovative environment.

Job Responsibilities:
  • Lead validation/qualification projects for QC laboratory and MFG equipment, instruments, software applications, and computer systems per applicable procedures.
  • Utilize in-depth technical knowledge to review, approve, and execute system life cycle documentation, including VP, RRA, RS, IOPQ protocols, decommissioning protocols, other compliance-related protocols/reports, change control requests, validation protocols/reports as applicable.
  • Assist with and plan training for teams and support completion of projects to milestones.
  • Evaluate and ensure compliance with platform, procedures, and Global QC vision (global harmonization).
Requirements:
  • Bachelor's degree in Life Science, Computer Science, or Engineering with a minimum of 4 years of quality experience in a pharmaceutical or biotech manufacturing environment.
  • Technical knowledge regarding QC analytical equipment and instrument systems, lab methodology (as appropriate).
  • Demonstrated strong oral and written communication skills; ability to communicate with management, peers, and subordinates effectively.
  • Strong organizational and project management skills; ability to multi-task and coordinate multiple activities in parallel.
Preferred Skills:
  • Working knowledge of GAMP 5 for GxP Computerized Systems and/or USP Analytical Instrument Qualification.
  • Experience with QUMAS DocCompliance, KNEAT, TrackWise, NuGenesis SDMS, MS Sharepoint.
About Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.

What You'll Do

You will serve within the Global QC Instrument and Equipment Strategy team. The team is responsible for leading the harmonization effort of QC and MFG analytical equipment and instrument systems across sites, providing project management oversight for qualification, validation, decommissioning, and integration with computer systems for instruments and equipment, supporting system administration activities during validation, and managing the annual CAPEX budgeting and purchasing process.

The estimated salary for this role is $85,000 - $110,000 per year, depending on location and experience.



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