Senior QC Analyst in Hertfordshire

Senior QC Analyst – Pharmaceutical Manufacturing
Location: North West London / Hertfordshire border | Permanent, full-time
 

The company
Our client is an MHRA-licensed UK manufacturer, working from a single modern site on the North West London / Hertfordshire border. They make pharmaceuticals and medical devices, both for their own brands and as a contract manufacturer for partner businesses. They're now looking for an experienced Senior QC Analyst to join their Quality Control laboratory. It's a senior, hands-on role: you'll bring strong technical expertise, lead investigations, take ownership of equipment and documentation standards, and help train and develop junior analysts.
 

The role
You'll test raw materials, stability samples, in-process samples and finished products, using validated and compendial methods. You'll be the lab's go-to person for chromatography, investigations and documentation, and someone colleagues rely on for knowledge and support. Because it's a single site, you'll work closely with Production, QA and Technical teams, contribute to cross-functional projects and see the impact of your work directly.

Key responsibilities
•    Testing raw materials, stability samples, in-process samples and finished products to validated and compendial methods, delivering results on time and right first time
•    Operating and troubleshooting analytical equipment, including HPLC, GC, UV, FTIR and Raman, and keeping instruments available for the lab
•    Reviewing analytical data, laboratory documentation and Certificates of Analysis
•    Leading OOS, OOT, deviation and complaint investigations, using trend analysis and root cause analysis to put effective, lasting CAPAs in place
•    Writing and reviewing SOPs, test methods, protocols, reports and quality records
•    Supporting method validation, verification and transfer
•    Training and mentoring junior analysts through to competency sign-off
•    Making sure work meets GMP, data integrity and laboratory safety requirements
•    Taking part in audits and MHRA and client inspections, and making sure resulting actions are closed on time
•    Identifying and leading continuous improvement initiatives in the lab
 

What success looks like
•    At least 95% of testing completed on time and at least 98% right first time
•    At least 95% instrument availability, with issues troubleshot promptly
•    At least 90% of OOS, OOT and deviation investigations closed on time
•    100% training compliance, with trainees successfully signed off as competent
•    Zero critical GMP, data integrity or safety breaches, and zero critical audit findings
•    At least two improvement initiatives implemented each year

What you'll need
•    A degree in Chemistry, Pharmaceutical Sciences or a related scientific discipline
•    At least 3 years' experience in a GMP pharmaceutical QC laboratory
•    Strong hands-on experience with HPLC and/or GC
•    Knowledge of BP, Ph. Eur., USP and JP pharmacopoeial testing
•    Experience leading OOS/OOT investigations, including root cause analysis and CAPA
•    A solid understanding of GMP, data integrity and method validation
•    Experience training or mentoring junior analysts
•    Strong analytical, problem-solving and communication skills

What you'll bring
You take ownership of your work and deliver on your commitments. You're confident making timely, evidence-based decisions, and you communicate clearly with colleagues across the site. You enjoy sharing your knowledge and supporting the team, adapt well to changing priorities, and are always looking for ways to improve how the lab works.