Analytical QC Analyst / Technology Transfer

Fastnet

Munster

On-site

EUR 60,000 - 80,000

Full time

35 hours ago
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Job summary

Fastnet is seeking an experienced QC Analytical Technology Transfer Analyst in Ireland's Munster region. The role combines hands‑on QC testing of biologics with analytical method transfer and verification, along with related technical documentation.

You will work with cross‑site QC teams, prepare transfer protocols, review data integrity, and support investigations and risk assessments. A degree in biochemistry or related field with about 5 years in GMP QC is required.

Qualifications

  • Degree in Biochemistry, Biotechnology, Chemistry, Pharmaceutical Science or a related discipline, with approximately 5 years' experience in a GMP‑regulated QC laboratory.
  • Strong hands‑on analytical testing experience with biologics or large‑molecule products, including knowledge of GMP, laboratory documentation and data integrity requirements.
  • Experience supporting analytical method transfer, verification or validation activities, including protocol execution, analytical data review and technical documentation.

Responsibilities

  • Perform hands‑on QC analytical testing of biologics and large‑molecule products, including routine testing and analytical method transfer/verification activities, in accordance with GMP requirements.
  • Prepare, execute and review analytical method transfer/verification protocols and reports, ensuring accurate documentation and data integrity.
  • Collaborate with sending‑site analytical/QC teams to obtain method packages, reference standards and comparator data, while supporting the planning and coordination of transfer activities.
  • Review analytical results, support investigations into testing discrepancies and contribute to risk assessments and FMEA activities associated with product transfers.

Skills

QC testing
Analytical transfer
Data integrity
GMP knowledge

Education

Biochemistry / Biotechnology / Chemistry degree

Job description

We are seeking an experienced QC Analytical Technology Transfer Analyst with strong hands-on experience in biologics and large-molecule testing within a GMP pharmaceutical environment. The role combines routine QC analytical testing with analytical method transfer, verification and associated technical documentation.

Responsibilities
  • Perform hands‑on QC analytical testing of biologics and large‑molecule products, including routine testing and analytical method transfer/verification activities, in accordance with GMP requirements.
  • Prepare, execute and review analytical method transfer/verification protocols and reports, ensuring accurate documentation and data integrity.
  • Collaborate with sending‑site analytical/QC teams to obtain method packages, reference standards and comparator data, while supporting the planning and coordination of transfer activities.
  • Review analytical results, support investigations into testing discrepancies and contribute to risk assessments and FMEA activities associated with product transfers.
Requirements
  • Degree in Biochemistry, Biotechnology, Chemistry, Pharmaceutical Science or a related discipline, with approximately 5 years' experience in a GMP‑regulated QC laboratory.
  • Strong hands‑on analytical testing experience with biologics or large‑molecule products, including knowledge of GMP, laboratory documentation and data integrity requirements.
  • Experience supporting analytical method transfer, verification or validation activities, including protocol execution, analytical data review and technical documentation.
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