QC Biochemistry Reviewer

PE Global (UK); Blanchardstown; On-site; EUR 45,000 - 65,000; Part time

Job summary

PE Global (UK) is currently recruiting for a QC Biochemistry Reviewer for a leading multi-national Pharma client based in Dublin. This contract position requires a BSc in Biochemistry and 4-7 years of experience in a cGMP QC laboratory environment.

The role entails performing lab functions, following protocols for various tests, and providing technical support to QC analysts. Strong attention to detail and ability to work independently are essential for success in this position.

Qualifications

• BSc in Biochemistry or a biological/chemistry science, with 4-7 years’ experience.
• Working knowledge of the cGMP QC laboratory environment and equipment.
• Ability to follow written procedures with close attention to detail.

Responsibilities

• Perform all lab functions in compliance with cGMP.
• Conduct tests including gel electrophoresis and ELISA assays.
• Provide guidance to QC biochemistry analysts.

Skills

Working knowledge of cGMP QC laboratory

Attention to detail

Ability to function with minimal supervision

Experience with Gel electrophoresis

Experience with ELISA assays

Education

BSc in Biochemistry or equivalent

Tools

Softmax software

Job description

PE Global is currently recruiting for a QC Biochemistry Reviewer for a leading multi‑national Pharma client based in Dublin.

This is a contract position.

Role

The individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The QC Biochemistry Reviewer (Senior Analyst) is responsible for providing technical and laboratory support to the QC analysts in Alexion Dublin, specifically working with the team to troubleshoot issues that may arise. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and to pay close attention to detail. The individual must be able to perform routine tasks with a minimum of supervision.

Responsibilities

• Perform all lab functions in compliance with cGMP
• Follow written procedures for review of the following tests, as trained and qualified:
• Gel electrophoresis (SDS‑PAGE, IEF)
• ELISA and plate‑based assays (potency and residual assays such as HCP and ProA)
• Protein concentration
• Release, stability and in‑process review scheduling and testing.
• Recognize and report aberrant test results and sample conditions.
• Provide QC SME and day‑to‑day technical guidance to QC biochemistry analysts
• Training new analysts in review
• Drive continuous improvement initiatives within the QC department.
• Contribute to investigations/CAPAs in a timely manner.
• Ensure training is current for all job functions performed.
• Complete all required documentation legibly and accurately.
• Drive Right First Time improvements within the lab for documentation

Requirements

• BSc in Biochemistry or a biological/chemistry science, with 4‑7 years’ experience, or equivalent combination of education and experience.
• A working knowledge of the cGMP QC laboratory environment and equipment associated with testing of biopharmaceutical products.
• Ability to follow written procedures with close attention to detail.
• Ability to function with minimal supervision for routine job duties.
• A working knowledge of gel electrophoresis and ELISA assays (Softmax software).