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Senior Quality Assurance Specialist

1 month ago

Herlev, Herlev Kommune, Denmark Nordic Bioscience Full time
Drive Quality and Excellence at Nordic Bioscience

We are seeking a highly skilled and experienced Quality Assurance Professional to join our dynamic team at Nordic Bioscience. As a key member of our QA team, you will play a vital role in ensuring the highest standards of quality in our laboratory operations.

Key Responsibilities:
  • Provide expert support to the QA team and cross-functional project groups on industry standards and regulations, including GMP, GCP, GCLP, CAP, CLIA, ISO9001, ISO13485, ISO15189, and FDA 21 CFR part 11.
  • Collaborate with the QA Manager and colleagues to rotate through various roles during inspections from clients and authorities, including QA subject matter expert and audit host.
  • Lead investigations into quality-related issues, perform root cause analysis, and implement corrective and preventive actions.
  • Identify opportunities for process improvement through internal audits and overall enhancement of quality assurance practices with a focus on simplicity in all processes.
Requirements:
  • Experience from QA roles within the pharmaceutical or biotech industry.
  • Strong understanding of quality management systems and regulatory requirements, with effective communication skills.
  • Ability to perform under high-pressure situations, such as audits, where auditors challenge our processes.
  • Excellent English communication skills for internal and external communication.
  • Adaptability to changing tasks and project teams in a dynamic environment.
  • Innovative and solution-oriented mindset with the ability to think above and beyond own area to accommodate processes throughout the company during enhancement of quality.
About Nordic Bioscience

Nordic Bioscience is a research-driven company specializing in the development of biomarkers for diagnostics and prognosis of various chronic diseases. Our laboratory, located in Herlev, conducts analyses of clinical samples for external partners, including CROs and Pharma/Biotech companies.

We are committed to upholding the highest standards of quality and delivering top-notch data crucial for decision-making in clinical trials throughout drug development. Your role in the daily operations of our company will be instrumental in maintaining our commitment to excellence and dedication to our clients.