QC Analyst

QC Analyst (Technology Transfer Specialist)

The successful QC candidate will manage the analytical dimension of each product transfer method transfer and verification as a dedicated resource that removes this load from routine QC testing capacity. Experience (typically 4+ years) in a QC/analytical role within a GMP pharmaceutical environment, including exposure to analytical method transfer or verification.

Key Responsibilities

• Own analytical method transfer/verification protocols and reports, coordinating directly with QC.
• Interface with the sending site’s analytical/QC function to secure method packages, reference standards and comparator data.
• Plan and track the analytical method transfer schedule alongside the process transfer schedule.
• Support investigation of any analytical discrepancies identified during method transfer or verification.
• Contribute analytical risk input into the product transfer’s overall FMEA/risk assessment. Essential Qualifications & Experience
• Working knowledge of analytical method validation/transfer principles (e.g. ICH Q2) and GMP documentation requirements.
• Degree in chemistry, biochemistry, pharmaceutical science or a related discipline. Desirable
• Direct experience running an analytical technology transfer tracker or leading method transfer for a sterile injectable product.
• Familiarity with analytical methods typical of sterile fill-finish products (e.g. sterility, endotoxin, particulate matter, container-closure integrity). Key Interfaces Tech Transfer/NPI Lead and team, QC/Analytical, Regulatory Affairs/CMC, sending-site analytical/QC teams.

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