Quality Control Analyst

Summary of the role

A Quality Control (QC) Analyst is a hands-on professional who plays a critical role in ensuring that every product manufactured meets the required specifications and safety standards. They are the scientists in the lab, meticulously testing raw materials, in-process samples, and final products to verify their quality.

A Quality Control Analyst is responsible for performing a variety of analytical and microbiological tests to ensure that medicinal products are safe, pure, and effective. Unlike a Quality Assurance (QA) role which focuses on the entire system, a QC role is specifically about testing the product itself. They work in a laboratory setting and are the final checkpoint for product quality before a batch can be considered for release.

This role can have a number of different job titles such as Quality Control Scientist, Analytical Scientist/Chemist or Laboratory Analyst.

Typical Duties

The duties of a QC Analyst are highly practical and laboratory-based:

• Analytical Testing: Performing a range of tests on raw materials, in-process samples, and final products. This could include techniques like HPLC (High-Performance Liquid Chromatography), PCR (Polymerase Chain Reaction), ELISA (Enzyme-Linked Immunosorbent Assay), and flow cytometry.
• Environmental Monitoring: In advanced therapies, a key duty is to perform environmental monitoring of the cleanroom or sterile manufacturing environment. This involves taking air and surface samples to check for any microbial contamination.
• Documentation: Meticulously and accurately documenting all test results, lab activities, and equipment usage in a lab notebook or a lab information management system (LIMS). This is critical for regulatory compliance and for demonstrating the quality of the product.
• Troubleshooting and Investigation: If a test result is “out-of-specification” (OOS), you will be involved in the initial investigation to determine the root cause. This requires strong problem-solving skills and a logical approach.
• Equipment Maintenance and Calibration: You will be responsible for the day-to-day operation, cleaning, and calibration of laboratory equipment to ensure that all tests are performed accurately.

The core principles of QC are the same across life sciences, but the specific assays and techniques would differ:

Advanced Therapies: The testing would be highly focused on the purity, identity, potency, and safety of cell and gene therapies. This requires expertise in specialised techniques like cell-based assays and flow cytometry. The samples are often highly sensitive and have short shelf-lives, requiring a fast turnaround.

Wider Life Sciences: The testing would be more focused on a broader range of biopharmaceutical products, such as monoclonal antibodies or vaccines. The techniques might include large-scale protein analysis and traditional microbiology.

Key Skills and Qualifications (UK)

Essential Qualifications: A degree in a scientific field such as Chemistry, Biochemistry, Microbiology, or a related life science discipline is typically required.

Essential Skills:

• Technical Laboratory Skills: Proficiency in a range of analytical techniques is essential.
• Attention to Detail: Meticulousness and accuracy in performing tests and documenting results are non-negotiable.
• Problem-Solving: The ability to logically investigate and troubleshoot issues with tests or equipment.
• Communication: Clear and effective communication skills for reporting results and collaborating with other teams.

Desirable Certifications: A strong understanding of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) is essential. Any formal training or certification in these areas is a significant advantage.

Salary Expectations (UK)

Starting Salary: For an entry-level Quality Control Analyst in the UK, a starting salary is typically in the range of £25,000 – £32,000 per year.

After 3-4 Years: With a few years of experience, a strong track record, and proficiency in more advanced analytical techniques, a QC Analyst can expect to earn between £35,000 – £45,000. Progression to Senior Analyst or Team Lead roles would lead to even higher salaries.