Transfusion QC Technologist

Werfenlife SA.; New Jersey; On-site; USD 60,000 - 90,000; Full time

Job summary

Werfen is seeking a Quality Control Technologist - Transfusion in the United States. The role involves performing incoming, in-process, and final release testing in a GMP QC lab, reviewing documents, and ensuring compliance with cGMP and ISO regulations.

The ideal candidate has a Bachelor’s degree in a science field and at least 1 year of lab experience, with preference for GMP/commercial lab exposure. The position may require extra hours, and flexibility is expected.

Qualifications

• Education: Bachelor’s degree in a science related field required (e.g., Biology, chemistry, Biomedical).
• Experience: Minimum 1 year laboratory experience; GMP experience in pharma or medical devices preferred.
• Desirable: PCR experience and automated/manual pipetting across a range of volumes.

Responsibilities

• Performs incoming, in-process, and final testing and inspection per SOPs within defined timeframes.
• Uses test methods/equipment including PCR, gel electrophoresis, and DNA extraction.
• Analyzes data with product software; maintains accurate, cGMP compliant records.
• Follows ISO 13485, 21 CFR Part 820 and other medical device regulations; maintains clean work area.
• Reports out-of-spec results and deviations; assists investigations and root cause analyses.

Skills

Pipetting

Data analysis

Thermocycler operation

Education

Bachelor’s degree in a science related field

Tools

PCR

Gel electrophoresis

DNA extraction

Job description

Werfen is seeking a Quality Control Technologist - Transfusion in the United States. The role involves performing incoming, in-process, and final release testing in a GMP QC lab, reviewing documents, and ensuring compliance with cGMP and ISO regulations.

The ideal candidate has a Bachelor’s degree in a science field and at least 1 year of lab experience, with preference for GMP/commercial lab exposure. The position may require extra hours, and flexibility is expected.