QC Scientist (Biotechnology, Onsite, Ballerup)

Job summary

The QC lab department is seeking a Scientist to assist in establishing a GMP QC Laboratory. This role involves supporting innovative products through release and stability testing in accordance with ICH guidelines.

Qualifications

• Master's degree in natural science, biotechnology, or a related field with 2-4 years of experience in equipment qualification and maintenance.
• Proficiency with equipment such as Maurice, PA800, HPLC, UPLC, Spectrophotometer, pH meter, Turbidimeter, and/or Osmometer.
• Familiarity with GMP QC settings and audits.
• Experience in developing standard qualification flows for equipment.
• Involvement in writing general SOPs for equipment qualification is essential.
• Desirable experience with Empower, Spectramax, Biacore, and LIMS (LabVantage).

Responsibilities

• Establish and standardize qualification processes for new equipment.
• Author and review qualification procedures and documentation activities for equipment qualification and troubleshooting.
• Write Change Controls, URS, IQ/OQ, and PQ protocols and reports.
• Collaborate closely with QC Subject Matter Experts (SMEs).

Skills

• Strong problem-solving abilities rooted in scientific methods.
• Excellent collaboration skills with diverse teams.
• Ability to innovate and adapt in a fast-paced environment.
• Detail-oriented with a commitment to precision and excellence.

Education

• Master's degree in a relevant scientific discipline.

Tools

• Experience with laboratory instruments and software such as Empower, Spectramax, Biacore, and LIMS (LabVantage).