Quality Assurance

Summary of the role

Quality Assurance are the guardians of quality, ensuring that every process, from research to manufacturing to distribution, is compliant with regulations and company standards. Their work is essential for patient safety and for maintaining a company’s reputation and license to operate.

A Quality Assurance Officer designs, implements, and monitors the systems and processes that ensure a product is manufactured to a consistent and high standard. They are responsible for the entire quality management system (QMS), which is the framework of policies, procedures, and documentation that guides a company’s operations. Unlike a quality control role which focuses on testing a product, a QA role is about ensuring that the process to make the product is correct from the start.

Typical Duties

The duties of a QA Officer are broad and involve a great deal of oversight and documentation:

• Documentation Control: You will be responsible for creating, reviewing, and approving a wide range of documents, including Standard Operating Procedures (SOPs), batch records, and manufacturing protocols. You’ll ensure that all documentation is accurate, up-to-date, and compliant with regulations.
• Deviation and Investigation Management: When an unexpected event or “deviation” occurs during a manufacturing run, you will lead or participate in the investigation to determine its root cause. You’ll then ensure that a CAPA (Corrective and Preventive Action) plan is put in place to prevent the issue from happening again.
• Auditing: You will conduct both internal and external audits to ensure that a company’s processes and those of its suppliers are compliant with GMP and other quality standards. This includes preparing for and participating in inspections from regulatory bodies like the MHRA.
• Training: You’ll be responsible for training new employees and providing refresher training to existing staff on quality standards and procedures.
• Change Control: Any proposed change to a manufacturing process, piece of equipment, or document must go through a formal “change control” process. A QA Officer is responsible for reviewing and approving these changes to ensure they won’t negatively impact product quality.

The core principles of QA are universal, but the specific application is different between advanced therapies and broader life sciences:

Advanced Therapies: The work would be highly focused on the unique challenges of cell and gene therapies, such as the short shelf life, personalised nature, and complex supply chain. You would be deeply involved in ensuring that a product is not contaminated and that the patient’s cells are handled with the utmost care.

Wider Life Sciences: The work would be similar but on a potentially larger scale, dealing with a broader range of products like monoclonal antibodies, vaccines, or traditional small-molecule drugs. The focus would be on process robustness and efficiency in a large-scale manufacturing environment.

Key Skills and Qualifications (UK)

Essential Qualifications: A degree in a scientific or engineering discipline (e.g., Biochemistry, Microbiology, Chemical Engineering) is typically required. Many QA professionals also have a Master’s degree in a relevant field.

Essential Certifications: A deep and practical understanding of Good Manufacturing Practice (GMP) is absolutely essential. Many employers look for candidates who have formal training or a certification in GMP. Knowledge of other quality systems like ISO 9001 is also highly desirable.

Essential Skills:

• Attention to Detail: Meticulousness is non-negotiable. QA is all about ensuring every detail is correct.
• Problem-Solving: The ability to logically investigate a deviation and determine a root cause is a key skill.
• Communication: Excellent written and verbal communication skills are necessary for writing clear documentation, training staff, and interacting with regulators.
• Regulatory Knowledge: A strong understanding of the regulations governing medicinal products in the UK (and often the EU and US) is vital.

Salary Expectations (UK)

Starting Salary: For an entry-level Quality Assurance Officer, a starting salary is typically in the range of £27,000 – £35,000 per year. This can vary depending on location and the size of the company.

After 3-4 Years: With a few years of experience, a strong track record, and a demonstrated ability to take on more complex responsibilities, a QA Officer can expect to earn between £40,000 – £55,000 or more. Progression to Senior QA Officer or Quality Manager roles will see salaries rise significantly.