Senior QC Analyst

Adepto Technical Recruitment Ltd; Watford; On-site; GBP 42,000 - 56,000; Full time

Job summary

Adepto Technical Recruitment Ltd represents a client seeking a Senior QC Analyst to join a GMP pharmaceutical QC laboratory on a full-time basis. You'll test materials, stability and in-process samples to validated methods and support investigations in a multi-disciplinary site near North West London / Hertfordshire border.

You'll lead or assist investigations, write robust SOPs, support method validation and mentor junior staff while ensuring data integrity and regulatory compliance across QA

Qualifications

• A degree in Chemistry, Pharmaceutical Sciences or a related scientific discipline.
• 3+ years' experience in a GMP pharmaceutical QC laboratory.
• Hands-on experience with HPLC and/or GC.
• Knowledge of BP, Ph. Eur., USP and JP pharmacopoeial testing.
• Experience with OOS/OOT investigations and CAPA management.
• GMP, data integrity and method validation understanding.
• Strong analytical, problem-solving and communication skills.

Responsibilities

• Test raw materials, stability samples, in-process samples and finished products to validated and compendial methods.
• Operate and troubleshoot analytical equipment including HPLC, GC, UV, FTIR and Raman.
• Review analytical data, laboratory documentation and Certificates of Analysis.
• Lead or support OOS, OOT, deviation and complaint investigations with root cause and CAPA.
• Write and review SOPs, test methods, protocols, reports and quality records.
• Support method validation, verification and transfer.
• Train and mentor junior analysts through to competency sign-off.
• Ensure work complies with GMP, data integrity and safety requirements.
• Participate in audits, MHRA and client inspections and continuous improvement.

Skills

HPLC

GC

GMP

OOS/OOT investigations

Data integrity

Method validation

Analytical skills

Problem solving

Communication

Education

Chemistry/Pharmaceutical Sciences degree

Job description

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 in 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. You'll bring technical expertise, support investigations and help 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. Because it's a single site, you'll work closely with Production, QA and Technical teams and can 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
• Operating and troubleshooting analytical equipment, including HPLC, GC, UV, FTIR and Raman
• Reviewing analytical data, laboratory documentation and Certificates of Analysis
• Leading or supporting OOS, OOT, deviation and complaint investigations, including root cause analysis and CAPA
• 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, MHRA and client inspections, and continuous improvement

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 with OOS/OOT investigations and CAPA management
• A solid understanding of GMP, data integrity and method validation
• Strong analytical, problem-solving and communication skills

What you'll bring

You pay close attention to detail and take ownership of your work. You're confident making evidence-based decisions, and you enjoy sharing your knowledge and supporting the people around you. You'll also adapt well to changing priorities and look for ways to improve how the lab works